Hemodynamic Resuscitation and Monitoring in Early Sepsis
NCT ID: NCT04143035
Last Updated: 2022-10-24
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
Recruitment Status
UNKNOWN
Total Enrollment
500 participants
Study Classification
OBSERVATIONAL
Study Start Date
2019-10-22
Study Completion Date
2023-01-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
"Hemodynamic Resuscitation and Monitoring in Early Sepsis (HERMES Study)" involves recording of patient's medical data related to that has been collected as part of his/her routine medical care in ICU.
Presently there is no data from Indian ICUs on the way patients in early sepsis are resuscitated and monitored. There may exist a wide variation in clinical practice. The investigators would like to conduct an observational study in various levels of Indian ICUs, to prospectively collect data on adult patients admitted to ICU with early sepsis in a 60-day window period. Investigator would like to study the hemodynamic resuscitation and monitoring performed in these patients. In addition, Investigator would like to identify factors associated with improved outcomes and achieving the goals of the sepsis bundles in one, three and six hours.
The objectives of the study is to capture the patient characteristics and hemodynamic resuscitation and monitoring practices in patients presenting with early sepsis and hypotension to Indian ICUs
Investigator plan to recruit 50 -100 centers nationwide. Each center will be asked to collect data from at least 10 patients in a maximum time window of 60 days. A convenience sample of minimum 500 patients presenting to ICU with suspected sepsis and hypotension will be taken.
Each Centre will guarantee the integrity of data collection and ensure timely completion of the case record forms. Each center will select a 60 day window period for patient recruitment. The start date may be anytime any time between 1st August to 15th October 2019. Therefore, the recruitment window period will end for a respective centre, anytime between 30th September and 14th December 2019, depending on the start date. All consecutive patients in the 60-day period will be screened and those eligible will be enrolled.
This is an ISCCM(Indian Society of Critical Care Medicine) Research Committee funded study. The ISCCM will fund the Principal Investigator for all expenses related software development, website hosting, secretarial assistance and miscellaneous expenses related to the conduct of the study, data analysis and publication. No funding will be given to the investigators from the various participating centers for contributing data.
Presently there is no data from Indian ICUs on the way patients in early sepsis are resuscitated and monitored. There may exist a wide variation in clinical practice. The investigators would like to conduct an observational study in various levels of Indian ICUs, to prospectively collect data on adult patients admitted to ICU with early sepsis in a 60-day window period. Investigator would like to study the hemodynamic resuscitation and monitoring performed in these patients. In addition, Investigator would like to identify factors associated with improved outcomes and achieving the goals of the sepsis bundles in one, three and six hours.
The objectives of the study is to capture the patient characteristics and hemodynamic resuscitation and monitoring practices in patients presenting with early sepsis and hypotension to Indian ICUs
Investigator plan to recruit 50 -100 centers nationwide. Each center will be asked to collect data from at least 10 patients in a maximum time window of 60 days. A convenience sample of minimum 500 patients presenting to ICU with suspected sepsis and hypotension will be taken.
Each Centre will guarantee the integrity of data collection and ensure timely completion of the case record forms. Each center will select a 60 day window period for patient recruitment. The start date may be anytime any time between 1st August to 15th October 2019. Therefore, the recruitment window period will end for a respective centre, anytime between 30th September and 14th December 2019, depending on the start date. All consecutive patients in the 60-day period will be screened and those eligible will be enrolled.
This is an ISCCM(Indian Society of Critical Care Medicine) Research Committee funded study. The ISCCM will fund the Principal Investigator for all expenses related software development, website hosting, secretarial assistance and miscellaneous expenses related to the conduct of the study, data analysis and publication. No funding will be given to the investigators from the various participating centers for contributing data.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Cardiac Output Monitoring Managing Intravenous Therapy (COMMIT) to Treat Emergency Department Severe Sepsis
NCT01484106
Sepsis
COMPLETED
NA
Evaluation of Plasma Angiotensin II and Angiotensin II Receptor Levels in Patients With Sepsis and Septic Shock: a Prospective Observational Study.
NCT04716842
Sepsis
Septic Shock
UNKNOWN
Preemptive Resuscitation for Eradication of Septic Shock
NCT01449721
Sepsis
Severe Sepsis
COMPLETED
NA
Monitoring Resuscitation in Severe Sepsis and Septic Shock
NCT01747057
Hemodynamics
UNKNOWN
NA
Comparison of Microcirculation Indexes and Hemodynamic Indexes to Guide Resuscitation in Patients With Septic Shock
NCT05118646
Sepsis
UNKNOWN
NA
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
INTRODUCTION Septic shock is the most commonly occurring of all types of shock.The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3) defines septic shock as a subset of sepsis in which particularly profound circulatory, cellular, and metabolic abnormalities are associated with a greater risk of mortality than with sepsis alone. Patients with septic shock can be clinically identified by a vasopressor requirement to maintain a mean arterial pressure of 65 mm Hg or greater and serum lactate level greater than 2 mmol/L (\>18 mg/dL) in the absence of hypovolemia. This combination is associated with hospital mortality rates greater than 40%.
The "sepsis bundle" has been central to the implementation of the Surviving Sepsis Campaign (SSC) from the first publication of its evidence-based guidelines in 2004 through subsequent editions. Developed separately from the guidelines publication by the SSC, the bundles have been the cornerstone of sepsis quality improvement since 2005. An updated version was published in 2016 "Surviving Sepsis Campaign: International Guidelines for Management of Sepsis and Septic Shock". There is compelling nature of the evidence in the literature which demonstrates an association between compliance with bundles and improved survival in patients with sepsis and septic shock. This has led to the adoption of the SSC measures by the National Quality Forum (NQF) and other departments. The important relationship between the bundles and survival was confirmed in a publication from this initiative.
The Surviving Sepsis Campaign released an updated one-hour sepsis bundle, which combines recommendations listed in the three-hour and six-hour bundles. This includes 5 elements: 1. measuring lactate levels 2. obtaining blood cultures before administering antibiotics 3. administering broad-spectrum antibiotics 4. fluid resuscitation for hypotension or lactate level ≥ 4 mmol/L and 5. use of vasopressors for hypotensive during or after fluid resuscitation to maintain MAP ≥ 65 mm Hg.
Presently there is no data from Indian ICUs on the way patients in early sepsis are resuscitated and monitored. There may exist a wide variation in clinical practice.The Investigator would like to conduct an observational study in various levels of Indian ICUs, to prospectively collect data on adult patients admitted to ICU with early sepsis in a 60-day window period. Investigator would like to study the hemodynamic resuscitation and monitoring performed in these patients. In addition, investigator would like to identify factors associated with improved outcomes and fulfilling the goals of the one hour SSC bundles within one, three and six hours in patients with sepsis and septic shock.
OBJECTIVES
1. To capture the patient characteristics and hemodynamic resuscitation and monitoring practices in patient presenting with early sepsis and hypotension to Indian ICUs
2. To determine various factors associated with improved survival in patients with septic shock
3. To determine factors associated with achieving the 1 hour, 3 hour and 6-hour resuscitation goals of the sepsis bundle in patients with septic shock
METHODS Study design- Prospective observational multi-center national cohort study.
Patient Recruitment
ISCCM members across India will be contacted to register their ICUs in the study, through emails sent from the ISCCM Research committee. Repeated emails will be sent over a two-month period. Hospitals with more than one ICU can enroll each of their ICUs separately. Each ICU will need to contribute a minimum of 10 adult patients with sepsis and hypotension in a 60 day window period.
Each center will designate a maximum of two local coordinators (PI and Co-PI) who will provide scientific and structural leadership in their centers. They will ensure that all local necessary ethical and regulatory approvals are obtained before the start of patient inclusion.
Local coordinators will guarantee the integrity of data collection and ensure timely completion of the case record forms. Each center will select a 60 day window period for patient recruitment. The start date may be anytime any time between 1st August to 15th October 2019. Therefore, the recruitment window period will end for a respective centre, anytime between 30th September and 14th December 2019, depending on the start date. All consecutive patients in the 60-day period will be screened and those eligible will be enrolled.
Data Collection
1. There will be no direct patient contact or intervention. Local coordinators will guarantee the integrity of data collection and ensure timely completion of CRFs (case record forms). Date related to the following will be collected prospectively from the charts:
2. Patient demographic data e.g. age, sex, comorbidities, likely source of sepsis
3. Total number of ICU patients, patients with sepsis and septic shock admitted to the ICU in the 60 days period
4. Patient clinical examination findings and severity of illness
5. Details of hemodynamic monitoring and other systemic monitoring and therapy performed in ICU e.g. fluid bolus, vasopressor agents, monitoring devices used, hemodynamic variables measured, mechanical ventilation, dialysis etc. in the first 3 days of ICU admission
6. Antibiotics administered and details of microbiology examinations
7. Adjunct therapies initiated for sepsis
8. ICU, hospital and 28-day mortality
Sample size The primary endpoint of study was to determine the incidence of ICU mortality in patients with septic shock admitted to Indian ICUs. The sample size calculation was done on the basis of INDICAPS I(Indian Intensive Care Case Mix and Practice Patterns Study-I) Study data (IJCCM April 2016). In this study the ICU mortality incidence was found to be 45% in patients with septic shock. Assuming the incidence rate found in this study, a sample size of 401 produces a two-sided 95% confidence interval with a width equal to 0.100 when the sample proportion is 0.450. Sample size calculation was done using PASS software. To account for attrition, Investigator will take a sample size of at least 450 patients. Investigator plan to recruit 50 -100 centers nationwide. Each center will be asked to collect data from at least 10 patients, hence investigator should be able to meet this target of \>450 patients.
Statistical analysis The primary objective of the study is to determine the patient characteristics and hemodynamic resuscitation and monitoring practices in patient presenting with early sepsis and hypotension to Indian ICUs which will be analyzed using descriptive statistics. To determine various factors associated with improved survival in patients with septic shock investigator will use the Fisher's exact test or Pearson's χ2 test. Univariable and Multivariable logistic regression models will be developed to assess the independent effects on ICU mortality. To determine factors associated with achieving the 1 hour SSC Sepsis resuscitation bundle in 1 hour, 3 hours and 6-hours in patients with sepsis and septic shock will be assessed by Fisher's exact test or Pearson's χ2 test. Univariable and Multivariable logistic regression models will be developed to assess the independent effects on ICU mortality of the 1 hour, 3 hour and 6-hour resuscitation goals of the sepsis bundle in patients with sepsis and septic shock. The overall performance of the internally validated model will be assessed using Nagelkerke's R2 (R squared in logistic regression). The higher Nagelkerke's R2, the greater the strength of the model. The ability of the models to identify ICU mortality will be quantified as the area under the receiver operating characteristic curve (AUC). The AUC ranges from 50% to 100%, indicating no discriminative capacity to perfect discriminative capacity. The agreement between predicted probabilities and observed frequencies of the outcome will be assessed by visually inspecting the calibration plot. Last, the Hosmer and Lemeshow goodness-of-fit statistic will be computed as a quantitative measure of accuracy. A high outcome of this statistic is related to a low p-value, which indicates a poor fit. All analysis will two sided, and significance will set at a p-value of 0.05. Statistical analyses will be performed using SPSS (the statistical package for social sciences) IBM Corp. Released 2017. IBM SPSS Statistics for Windows, Version 25.0. Armonk, New York: IBM Corp and R studio (version 1.2).
INSTITUTIONAL ETHICS COMMITTEE (IEC) APPROVAL The local hospital investigators should ensure that all necessary local ethical and regulatory approvals are obtained if required, before the start of the study in their institution.
CONSENT FOR DATA COLLECTION This is an observational study and involves capture of data from the patient charts. There is no direct patient contact or intervention, hence written, informed consent is not mandatory. However, if required by the institution, consent may be taken from the patients legally accepted representative (LAR). Sample short consent forms for patient data capture will be provided by the PI in English, Hindi and Marathi. This may be translated in various regional languages as required by the local investigator
STUDY FUNDING This is an ISCCM Research Committee funded study. The ISCCM will fund the Principal Investigator institution for all expenses related software development, website hosting, secretarial assistance and miscellaneous expenses related to the conduct of the study, data analysis and publication (against actual bills). No funding will be given to the investigators from the various participating centres for contributing data.
DATA STORAGE AND OWNERSHIP The Principal Investigator will have ownership of the data. The data will be stored in the Principal Investigators department at Tata Memorial Hospital, Mumbai for 10 years.
PUBLICATION AND AUTHORSHIP POLICY The main results of study will be published in a peer-reviewed medical journal. Authorship policy will follow the International Committee of Medical Journal Editors (ICMJE) recommendations. Authorship will be considered based on contributions the study design and protocol development, recruitment of patients, data acquisition and cleaning, analysis and interpretation of the data, manuscript writing and final approval of the version to be published and agreement to be accountable for all aspects of the work, in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.
Steering Committee - Members of the Steering Committee will include 7 members from the Principal Investigators center and 8 -10 experts from across the country. They will be involved and provide active guidance from inception till publication of the study.
Writing committee and main author list - Members of the steering committee and Principal Investigator from the top 3 centers with highest number of patient recruitment.
The Principal Investigator and Co-Principal Investigator from each participating ICU will be in the list of study collaborators and their names will be in the publication. The names of all the investigators will be indexed in PubMed depending on the journal policy.
SECONDARY ANALYSES After publication of the primary results, on request, the pooled dataset will be available for investigators for secondary analysis, after judgment and approval of scientific quality and validity by the steering committee. Before submission, the final version of all manuscripts related to the study dataset must be approved by the steering committee. The members of the writing committee will be authors of the publications derived from the study dataset.
The "sepsis bundle" has been central to the implementation of the Surviving Sepsis Campaign (SSC) from the first publication of its evidence-based guidelines in 2004 through subsequent editions. Developed separately from the guidelines publication by the SSC, the bundles have been the cornerstone of sepsis quality improvement since 2005. An updated version was published in 2016 "Surviving Sepsis Campaign: International Guidelines for Management of Sepsis and Septic Shock". There is compelling nature of the evidence in the literature which demonstrates an association between compliance with bundles and improved survival in patients with sepsis and septic shock. This has led to the adoption of the SSC measures by the National Quality Forum (NQF) and other departments. The important relationship between the bundles and survival was confirmed in a publication from this initiative.
The Surviving Sepsis Campaign released an updated one-hour sepsis bundle, which combines recommendations listed in the three-hour and six-hour bundles. This includes 5 elements: 1. measuring lactate levels 2. obtaining blood cultures before administering antibiotics 3. administering broad-spectrum antibiotics 4. fluid resuscitation for hypotension or lactate level ≥ 4 mmol/L and 5. use of vasopressors for hypotensive during or after fluid resuscitation to maintain MAP ≥ 65 mm Hg.
Presently there is no data from Indian ICUs on the way patients in early sepsis are resuscitated and monitored. There may exist a wide variation in clinical practice.The Investigator would like to conduct an observational study in various levels of Indian ICUs, to prospectively collect data on adult patients admitted to ICU with early sepsis in a 60-day window period. Investigator would like to study the hemodynamic resuscitation and monitoring performed in these patients. In addition, investigator would like to identify factors associated with improved outcomes and fulfilling the goals of the one hour SSC bundles within one, three and six hours in patients with sepsis and septic shock.
OBJECTIVES
1. To capture the patient characteristics and hemodynamic resuscitation and monitoring practices in patient presenting with early sepsis and hypotension to Indian ICUs
2. To determine various factors associated with improved survival in patients with septic shock
3. To determine factors associated with achieving the 1 hour, 3 hour and 6-hour resuscitation goals of the sepsis bundle in patients with septic shock
METHODS Study design- Prospective observational multi-center national cohort study.
Patient Recruitment
ISCCM members across India will be contacted to register their ICUs in the study, through emails sent from the ISCCM Research committee. Repeated emails will be sent over a two-month period. Hospitals with more than one ICU can enroll each of their ICUs separately. Each ICU will need to contribute a minimum of 10 adult patients with sepsis and hypotension in a 60 day window period.
Each center will designate a maximum of two local coordinators (PI and Co-PI) who will provide scientific and structural leadership in their centers. They will ensure that all local necessary ethical and regulatory approvals are obtained before the start of patient inclusion.
Local coordinators will guarantee the integrity of data collection and ensure timely completion of the case record forms. Each center will select a 60 day window period for patient recruitment. The start date may be anytime any time between 1st August to 15th October 2019. Therefore, the recruitment window period will end for a respective centre, anytime between 30th September and 14th December 2019, depending on the start date. All consecutive patients in the 60-day period will be screened and those eligible will be enrolled.
Data Collection
1. There will be no direct patient contact or intervention. Local coordinators will guarantee the integrity of data collection and ensure timely completion of CRFs (case record forms). Date related to the following will be collected prospectively from the charts:
2. Patient demographic data e.g. age, sex, comorbidities, likely source of sepsis
3. Total number of ICU patients, patients with sepsis and septic shock admitted to the ICU in the 60 days period
4. Patient clinical examination findings and severity of illness
5. Details of hemodynamic monitoring and other systemic monitoring and therapy performed in ICU e.g. fluid bolus, vasopressor agents, monitoring devices used, hemodynamic variables measured, mechanical ventilation, dialysis etc. in the first 3 days of ICU admission
6. Antibiotics administered and details of microbiology examinations
7. Adjunct therapies initiated for sepsis
8. ICU, hospital and 28-day mortality
Sample size The primary endpoint of study was to determine the incidence of ICU mortality in patients with septic shock admitted to Indian ICUs. The sample size calculation was done on the basis of INDICAPS I(Indian Intensive Care Case Mix and Practice Patterns Study-I) Study data (IJCCM April 2016). In this study the ICU mortality incidence was found to be 45% in patients with septic shock. Assuming the incidence rate found in this study, a sample size of 401 produces a two-sided 95% confidence interval with a width equal to 0.100 when the sample proportion is 0.450. Sample size calculation was done using PASS software. To account for attrition, Investigator will take a sample size of at least 450 patients. Investigator plan to recruit 50 -100 centers nationwide. Each center will be asked to collect data from at least 10 patients, hence investigator should be able to meet this target of \>450 patients.
Statistical analysis The primary objective of the study is to determine the patient characteristics and hemodynamic resuscitation and monitoring practices in patient presenting with early sepsis and hypotension to Indian ICUs which will be analyzed using descriptive statistics. To determine various factors associated with improved survival in patients with septic shock investigator will use the Fisher's exact test or Pearson's χ2 test. Univariable and Multivariable logistic regression models will be developed to assess the independent effects on ICU mortality. To determine factors associated with achieving the 1 hour SSC Sepsis resuscitation bundle in 1 hour, 3 hours and 6-hours in patients with sepsis and septic shock will be assessed by Fisher's exact test or Pearson's χ2 test. Univariable and Multivariable logistic regression models will be developed to assess the independent effects on ICU mortality of the 1 hour, 3 hour and 6-hour resuscitation goals of the sepsis bundle in patients with sepsis and septic shock. The overall performance of the internally validated model will be assessed using Nagelkerke's R2 (R squared in logistic regression). The higher Nagelkerke's R2, the greater the strength of the model. The ability of the models to identify ICU mortality will be quantified as the area under the receiver operating characteristic curve (AUC). The AUC ranges from 50% to 100%, indicating no discriminative capacity to perfect discriminative capacity. The agreement between predicted probabilities and observed frequencies of the outcome will be assessed by visually inspecting the calibration plot. Last, the Hosmer and Lemeshow goodness-of-fit statistic will be computed as a quantitative measure of accuracy. A high outcome of this statistic is related to a low p-value, which indicates a poor fit. All analysis will two sided, and significance will set at a p-value of 0.05. Statistical analyses will be performed using SPSS (the statistical package for social sciences) IBM Corp. Released 2017. IBM SPSS Statistics for Windows, Version 25.0. Armonk, New York: IBM Corp and R studio (version 1.2).
INSTITUTIONAL ETHICS COMMITTEE (IEC) APPROVAL The local hospital investigators should ensure that all necessary local ethical and regulatory approvals are obtained if required, before the start of the study in their institution.
CONSENT FOR DATA COLLECTION This is an observational study and involves capture of data from the patient charts. There is no direct patient contact or intervention, hence written, informed consent is not mandatory. However, if required by the institution, consent may be taken from the patients legally accepted representative (LAR). Sample short consent forms for patient data capture will be provided by the PI in English, Hindi and Marathi. This may be translated in various regional languages as required by the local investigator
STUDY FUNDING This is an ISCCM Research Committee funded study. The ISCCM will fund the Principal Investigator institution for all expenses related software development, website hosting, secretarial assistance and miscellaneous expenses related to the conduct of the study, data analysis and publication (against actual bills). No funding will be given to the investigators from the various participating centres for contributing data.
DATA STORAGE AND OWNERSHIP The Principal Investigator will have ownership of the data. The data will be stored in the Principal Investigators department at Tata Memorial Hospital, Mumbai for 10 years.
PUBLICATION AND AUTHORSHIP POLICY The main results of study will be published in a peer-reviewed medical journal. Authorship policy will follow the International Committee of Medical Journal Editors (ICMJE) recommendations. Authorship will be considered based on contributions the study design and protocol development, recruitment of patients, data acquisition and cleaning, analysis and interpretation of the data, manuscript writing and final approval of the version to be published and agreement to be accountable for all aspects of the work, in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.
Steering Committee - Members of the Steering Committee will include 7 members from the Principal Investigators center and 8 -10 experts from across the country. They will be involved and provide active guidance from inception till publication of the study.
Writing committee and main author list - Members of the steering committee and Principal Investigator from the top 3 centers with highest number of patient recruitment.
The Principal Investigator and Co-Principal Investigator from each participating ICU will be in the list of study collaborators and their names will be in the publication. The names of all the investigators will be indexed in PubMed depending on the journal policy.
SECONDARY ANALYSES After publication of the primary results, on request, the pooled dataset will be available for investigators for secondary analysis, after judgment and approval of scientific quality and validity by the steering committee. Before submission, the final version of all manuscripts related to the study dataset must be approved by the steering committee. The members of the writing committee will be authors of the publications derived from the study dataset.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Septic Shock
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
Observational Model Type
CASE_ONLY
Study Time Perspective
PROSPECTIVE
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
No Intervention
No Intervention
Intervention Type
OTHER
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
1. Adult patients (≥ 18 years old)
2. Presenting to ICU with suspected sepsis
3. Presence of hypotension (Systolic BP ≤ 90 mmHg / Mean arterial pressure (MAP) ≤ 65mmhg or patient with Systolic BP \> 90 mmHg / MAP \>65mmHg on vasopressor.
2. Presenting to ICU with suspected sepsis
3. Presence of hypotension (Systolic BP ≤ 90 mmHg / Mean arterial pressure (MAP) ≤ 65mmhg or patient with Systolic BP \> 90 mmHg / MAP \>65mmHg on vasopressor.
Exclusion Criteria
1. Patient likely to be in shock due to reason other than sepsis (e.g. cardiogenic or hemorrhagic shock)
2. Decision taken for not intubating / ventilating /aggressive resuscitation prior to ICU admission
3. Patient transferred from another ICU OR another hospital (only if stay \>7 days)
2. Decision taken for not intubating / ventilating /aggressive resuscitation prior to ICU admission
3. Patient transferred from another ICU OR another hospital (only if stay \>7 days)
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Indian Society of Critical Care Medicine
OTHER
Sponsor Role
collaborator
Tata Memorial Centre
OTHER
Sponsor Role
lead
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Sheila Nainan Myatra
Professor
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Sheila N Myatra, MD
Role: PRINCIPAL_INVESTIGATOR
Tata Memorial Hospital, Parel, Mumbai-12
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
AIIMS Patna
Patna, Bihar, India
Site Status
All india institute of medical sciences
Patna, Bihar, India
Site Status
Anant Institute of Medical Sciences
Jabalpur, Madhya Pradesh, India
Site Status
Breach Candy Hospital Trust
Mumbai, Maharashtra, India
Site Status
Criticare Hospital and Research Institute
Nagpur, Maharashtra, India
Site Status
Galaxy care hospital
Pune, Maharashtra, India
Site Status
Sanjeevan Hospital
Pune, Maharashtra, India
Site Status
Dayanand Medical College and Hospital
Ludhiana, Punjab, India
Site Status
Eternal Hospital
Jaipur, Rajasthan, India
Site Status
Kamlesh Kanwar Shekhawat
Udaipur, Rajasthan, India
Site Status
Pims
Udaipur, Rajasthan, India
Site Status
Sarvodaya hospital and research centre
Farīdābād, Uttar Pradesh, India
Site Status
Fortune Hospital
Kanpur, Uttar Pradesh, India
Site Status
Sir Sundar lal Hospital, IMS, BHU, Varanasi
Varanasi, Uttar Pradesh, India
Site Status
Sir Sunderlal Hospital
Varanasi, Uttar Pradesh, India
Site Status
Nayati Hospital - Trauma & Acute Care Centre
Agra, , India
Site Status
Purushottam das Savitri Devi Cancer center
Agra, , India
Site Status
Pushpanjali Hospital
Agra, , India
Site Status
Rainbow Hospitals
Agra, , India
Site Status
Saideep Healthcare and Research Pvt Ltd
Ahilyanagar, , India
Site Status
Narayana Multispeciality Hospital
Ahmedabad, , India
Site Status
Sterling hospital
Ahmedabad, , India
Site Status
Zydus Hospitals Ahmedabad
Ahmedabad, , India
Site Status
J N Medical College & Hospital
Aligarh, , India
Site Status
Ohm Trauma centre and critical care
Aligarh, , India
Site Status
Emc hospital
Amritsar, , India
Site Status
Fortis Escorts Hospital Amritsar
Amritsar, , India
Site Status
Kamalnayan Bajaj hospital
Aurangabad, , India
Site Status
Mgm Medical College Hospital and Medical Centre Research Institute(McRi)
Aurangabad, , India
Site Status
Oriion Citicare Superspeciality Hospital
Aurangabad, , India
Site Status
Shraddha hospital and critical care center
Aurangabad, , India
Site Status
Bhagwan Mahaveer Jain Hospital
Bangalore, , India
Site Status
Columbiaasia Referral Hospital, Yeshwantpur
Bangalore, , India
Site Status
Cytecare Cancer Hospital
Bangalore, , India
Site Status
Health care Global (HCG)
Bangalore, , India
Site Status
Shifaa hospital
Bangalore, , India
Site Status
Shri Ram Murti Smarak Institute of Medical Sciences
Bareilly, , India
Site Status
Geeta Hospital and research centre
Barnagar, , India
Site Status
Aster R V Hospital
Bengaluru, , India
Site Status
Manipal hospital
Bengaluru, , India
Site Status
Mazumdar Shaw Medical Center
Bengaluru, , India
Site Status
Regal Hospital
Bengaluru, , India
Site Status
St John's Medical College Hospital
Bengaluru, , India
Site Status
Vydehi Institute of Medical Sciences and Research Centre
Bengaluru, , India
Site Status
Apollo Hospitals
Bhubaneshwar, , India
Site Status
Amri hospital ICU -1
Bhubaneswar, , India
Site Status
AMRI Hospitals
Bhubaneswar, , India
Site Status
Amri Hospital
Bhubaneswar, , India
Site Status
Apollo Hospitals
Bhubaneswar, , India
Site Status
Apollo Hospital
Bhubaneswar, , India
Site Status
BR Life Kalinga Hispital
Bhubaneswar, , India
Site Status
Care Hospitals
Bhubaneswar, , India
Site Status
Care Hospital
Bhubaneswar, , India
Site Status
Gudage Hospital
Bidar, , India
Site Status
Apollo Hospital Icu-1
Bilāspur, , India
Site Status
Apollo Hospital
Bilāspur, , India
Site Status
Ayush Hospital
Bījāpur, , India
Site Status
K.M.Memorial hospital and research centre
Bokāro, , India
Site Status
PGIMER
Chandigarh, , India
Site Status
Apollo Hospitals Enterprise limited
Chennai, , India
Site Status
Billroth hospital
Chennai, , India
Site Status
Dr.Rela Institute and Medical Centre
Chennai, , India
Site Status
Mgm Healthcare Ltd.
Chennai, , India
Site Status
Sri Ramachandra Hospital
Chennai, , India
Site Status
Sri Ramchandra Medical Centre
Chennai, , India
Site Status
Kovai Medical Center Hospital and Research
Coimbatore, , India
Site Status
Royal Care Super Speciality Hospital
Coimbatore, , India
Site Status
Ashwini Hospital
Cuttack, , India
Site Status
Goodluck Hospital
Cuttack, , India
Site Status
Scb Medical College and Hospital
Cuttack, , India
Site Status
SCB Medical College
Cuttack, , India
Site Status
Paras Global Hospital
Darbhanga, , India
Site Status
Dharmshila Narayana Superspeciality Hospital
Delhi, , India
Site Status
Dr. Ram Manohar Lohia Hospital ,New Delhi
Delhi, , India
Site Status
Dr. Ram Manohar Lohia Hospital
Delhi, , India
Site Status
kailash Hospital and heart Institute
Delhi, , India
Site Status
Pushpawati Singhania Research Institute
Delhi, , India
Site Status
Sir Ganga Ram Hospital
Delhi, , India
Site Status
BKL Walawalkar Hospital
Dervān, , India
Site Status
Muthukrishnan Periasamy
Erode, , India
Site Status
Qrg Healthcity
Faridabad, , India
Site Status
Yashoda super specialty hospital, kaushambi
Ghaziabad, , India
Site Status
City Hospital
Gorakhpur, , India
Site Status
Dr.Ramesh Cardiac and Multiplicity PVT LTD
Guntur, , India
Site Status
GBR super speciality hospitals
Guntur, , India
Site Status
Lalitha Super Specialities Hospital
Guntur, , India
Site Status
Samistha Hospital and Research Institute
Guntur, , India
Site Status
Medanta Medicity
Gurgaon, , India
Site Status
Medanta the medicity hospital
Gurgaon, , India
Site Status
Medanta the medicity
Gurgaon, , India
Site Status
Narayana Super Specialty Hospital
Gurgaon, , India
Site Status
VPS Medeor Hospital
Gurgaon, , India
Site Status
Apollo Hospitals Guwahati
Guwahati, , India
Site Status
Apollo hospitals
Guwahati, , India
Site Status
Ayursundra Superspecialty hospital
Guwahati, , India
Site Status
Dispur Hospitals pvt Ltd
Guwahati, , India
Site Status
Gnrc Hospitas, Dispur
Guwahati, , India
Site Status
Health City
Guwahati, , India
Site Status
Nemcare Hospital
Guwahati, , India
Site Status
Santhi Hospital
Hosūr, , India
Site Status
Aig Hospitals, Gachibowli
Hyderabad, , India
Site Status
Apollo Health City ICU-1
Hyderabad, , India
Site Status
Apollo health city
Hyderabad, , India
Site Status
Aware Gleneagles Global Hospital
Hyderabad, , India
Site Status
Care hospital and institute of medical sciences
Hyderabad, , India
Site Status
Care hospitals banjara
Hyderabad, , India
Site Status
CENTURY hospital
Hyderabad, , India
Site Status
Century Super Speciality Hospital
Hyderabad, , India
Site Status
Continental Hospitals
Hyderabad, , India
Site Status
Gleneagles Global Hospital
Hyderabad, , India
Site Status
Krishna Institute of Medical Sciences
Hyderabad, , India
Site Status
Rainbow childrnes hospital
Hyderabad, , India
Site Status
South Central Railway Hospital ICU-1
Hyderabad, , India
Site Status
South Central Railway Hospital
Hyderabad, , India
Site Status
Virinchi Hospital
Hyderabad, , India
Site Status
Yashoda Hospital
Hyderabad, , India
Site Status
Choithram hospital
Indore, , India
Site Status
Dodeja Hospital
Jabalpur, , India
Site Status
Apex Hospital
Jaipur, , India
Site Status
Manipal hospital
Jaipur, , India
Site Status
Shubh Hospital
Jaipur, , India
Site Status
shrimann superspeciality hospital ICU-1
Jalandhar, , India
Site Status
Shrimann Superspeciality Hospital
Jalandhar, , India
Site Status
Kripa Critical Care and Trauma Centre
Jalgaon, , India
Site Status
Smvd Narayana Superspeciality Hospital
Jammu, , India
Site Status
Tata Main Hospital
Jamshedpur, , India
Site Status
All India Institute of Medical Sciences, jodhpur
Jodhpur, , India
Site Status
Ved Hospital
Kalyān, , India
Site Status
Abha superspeciality hospital
Kanpur, , India
Site Status
Regency hospital ltd tower 1
Kanpur, , India
Site Status
Shree krishna hospital ICU-1
Karamsad, , India
Site Status
Shree Krishna Hospital
Karamsad, , India
Site Status
Sankalpa hospital
Khammam, , India
Site Status
Amrita institute of Medical Sciences
Kochi, , India
Site Status
MOSC Medical College
Kochi, , India
Site Status
AMRI Hospital Mukundapur
Kolkata, , India
Site Status
AMRI Hospital, DHAKURIA
Kolkata, , India
Site Status
Apollo Gleneagles Hospital
Kolkata, , India
Site Status
Bellevue Clinic
Kolkata, , India
Site Status
Fortis Hospital Anandapur
Kolkata, , India
Site Status
Institute of Neurosciences Kolkata
Kolkata, , India
Site Status
Medica Superspecialty Hospital
Kolkata, , India
Site Status
Peerless Hospitex Hospital and Research Center Limited
Kolkata, , India
Site Status
Tata Medical Center
Kolkata, , India
Site Status
Travancore medical college,medicity
Kollam, , India
Site Status
Govt.Medical college
Kottayam, , India
Site Status
King George's Medical University
Lucknow, , India
Site Status
Christian Medical College
Ludhiana, , India
Site Status
Apollo speciality hospital
Madurai, , India
Site Status
Kasturba medical college, Manipal
Manipal, , India
Site Status
Nayati medicity hospital
Mathura, , India
Site Status
Manglam Hosp
Meerut, , India
Site Status
Metro Hospital and heart Institute
Meerut, , India
Site Status
Cheema Medical Complex
Mohali, , India
Site Status
Fortis Hospital
Mohali, , India
Site Status
MAX Superspecialty Hospital
Mohali, , India
Site Status
Asian Cancer Institute
Mumbai, , India
Site Status
Bhatia Hospital
Mumbai, , India
Site Status
Dr L H HIRANANDANI HOSPITAL
Mumbai, , India
Site Status
Fortis hiranandani hospital
Mumbai, , India
Site Status
Fortis Hospital Mulund
Mumbai, , India
Site Status
Fortis hospitals
Mumbai, , India
Site Status
Global Hospital,Parel
Mumbai, , India
Site Status
Global Hospital
Mumbai, , India
Site Status
Holy Family Hospital
Mumbai, , India
Site Status
Nanavati Hospital Icu-1
Mumbai, , India
Site Status
Nanavati hospital ICU-2
Mumbai, , India
Site Status
Nanavati Hospital Icu-3
Mumbai, , India
Site Status
Nanavati Hospital
Mumbai, , India
Site Status
Nanavati hosptial
Mumbai, , India
Site Status
Pd Hinduja National Hospital and Mrc
Mumbai, , India
Site Status
s.l.Rahej hospital- a fortis associate
Mumbai, , India
Site Status
Sir H N Reliance Foundation Hospital
Mumbai, , India
Site Status
Suasth Health Care
Mumbai, , India
Site Status
Tata Memorial Hospital (FICU)
Mumbai, , India
Site Status
Tata Memorial Hospital (SICU)
Mumbai, , India
Site Status
Wockhardt Hopsital South Mumbai
Mumbai, , India
Site Status
Cauvery Heart and multispeciality hospital
Mysore, , India
Site Status
Jss Hospital
Mysore, , India
Site Status
Gopalagowda Shanthaveri Memorial Hospital
Mysuru, , India
Site Status
Aditya Hospital
Nagpur, , India
Site Status
Dew medicare and Trinity Hospital
Nagpur, , India
Site Status
Dr V E Tambe Critical Care
Nagpur, , India
Site Status
Meditrina Institute Of Medical Scineces
Nagpur, , India
Site Status
Orange City Hospital And Research Institute
Nagpur, , India
Site Status
Rahate Surgical Hospital and Iccu
Nagpur, , India
Site Status
Shree Hospital and Critical Care Centre
Nagpur, , India
Site Status
Apollo Hospitals
Nashik, , India
Site Status
National Burns Centre
Navi Mumbai, , India
Site Status
Narayana Medical College Icu-1
Nellore, , India
Site Status
Narayana Medical College
Nellore, , India
Site Status
Simhapuri Hospital
Nellore, , India
Site Status
Batra Hospital & Medical Research Center
New Delhi, , India
Site Status
Batra Hospital
New Delhi, , India
Site Status
BLK hospital
New Delhi, , India
Site Status
Blk Superspeciality Hospital
New Delhi, , India
Site Status
Fortis Escorts Heart Institute
New Delhi, , India
Site Status
Fortis Hospital, Shalimar Bagh
New Delhi, , India
Site Status
GB Pant Institute of Post Graduate Medical Education & Research
New Delhi, , India
Site Status
Indraprastha Apollo Hospitals ICU-1
New Delhi, , India
Site Status
Indraprastha apollo hospitals
New Delhi, , India
Site Status
Max Super Specialty Hospital Patparganj
New Delhi, , India
Site Status
Northern railway central hospital
New Delhi, , India
Site Status
Sri balaji action medical institute ICU-1
New Delhi, , India
Site Status
Sri Balaji Action Medical Institute
New Delhi, , India
Site Status
Venkateshwar Hospital
New Delhi, , India
Site Status
Fortis Hospital
Noida, , India
Site Status
Promhex Multispeciality Hospital
Noida, , India
Site Status
Ojas hospital
Panchkula, , India
Site Status
All India Institute of Medical Sciences Patna
Patna, , India
Site Status
Indira Gandhi Institute of Medical Sciences
Patna, , India
Site Status
Prabhat Kumar
Patna, , India
Site Status
Bharati Vidyapeeth Deemed university and Medical College Hospital
Pune, , India
Site Status
Columbia Asia hospital
Pune, , India
Site Status
Jupiter Hospital
Pune, , India
Site Status
Niramaya Hoapital
Pune, , India
Site Status
Ruby Hall Clinic Icu-1
Pune, , India
Site Status
Ruby Hall Clinic ICU-2
Pune, , India
Site Status
Vishwaraj Hospital & Research Centre
Pune, , India
Site Status
Vishwaraj Hospital& Research Center
Pune, , India
Site Status
Om Hospital
Raipur, , India
Site Status
Pt. J. N. M. Medical College
Raipur, , India
Site Status
Ramskrishna care hospital
Raipur, , India
Site Status
Shree Narayana Hospital
Raipur, , India
Site Status
Genesis Multispeciality Hospital
Rajkot, , India
Site Status
Shree Giriraj Multispeciality hospital
Rajkot, , India
Site Status
Shree Giriraj Multispecialty Hospital
Rajkot, , India
Site Status
Sterling Hospital, Rajkot (A Division of Sterling Addlife India Private Limited)
Rajkot, , India
Site Status
Synergy superspeciality hospital
Rajkot, , India
Site Status
Bhagwan Mahavir Medica Superspecialty Hospital
Ranchi, , India
Site Status
Sagarshree Hospital
Sāgar, , India
Site Status
Abdul Waheed Mir
Srinagar, , India
Site Status
Sheri Kashmir Institute of Medical Sciences
Srinagar, , India
Site Status
Kiran Hospital
Surat, , India
Site Status
Shree Sardar Smarak Hospital
Surat, , India
Site Status
Trichy Srm Medical College Hospital & Research Centre
Tiruchirappalli, , India
Site Status
Believers Church Medical College and Hospital
Tiruvalla, , India
Site Status
Kerala Institute of Medical sciences
Trivandrum, , India
Site Status
Siddaganga hospital and research centre
Tūmulūru, , India
Site Status
Sterling Hospitals
Vadodara, , India
Site Status
Homi Bhaba Cancer Hospital & Pandit Madan Mohan Malviya Cancer Centre,Tata Memorial Centre,Varanasi
Varanasi, , India
Site Status
S S Hospital BHU VARANASI
Varanasi, , India
Site Status
Christian Medical College
Vellore, , India
Site Status
Nagarjuna hospital
Vijayawada, , India
Site Status
St Ann Hospital
Visakhapatnam, , India
Site Status
Samraksha super speciality
Warangal, , India
Site Status
Arnam Hospital
Wardha, , India
Site Status
Countries
Review the countries where the study has at least one active or historical site.
India
References
Explore related publications, articles, or registry entries linked to this study.
Vincent JL, De Backer D. Circulatory shock. N Engl J Med. 2013 Oct 31;369(18):1726-34. doi: 10.1056/NEJMra1208943. No abstract available.
Reference Type
BACKGROUND
Dellinger RP, Carlet JM, Masur H, Gerlach H, Calandra T, Cohen J, Gea-Banacloche J, Keh D, Marshall JC, Parker MM, Ramsay G, Zimmerman JL, Vincent JL, Levy MM; Surviving Sepsis Campaign Management Guidelines Committee. Surviving Sepsis Campaign guidelines for management of severe sepsis and septic shock. Crit Care Med. 2004 Mar;32(3):858-73. doi: 10.1097/01.ccm.0000117317.18092.e4.
Reference Type
BACKGROUND
Dellinger RP, Carlet JM, Masur H, Gerlach H, Calandra T, Cohen J, Gea-Banacloche J, Keh D, Marshall JC, Parker MM, Ramsay G, Zimmerman JL, Vincent JL, Levy MM. Surviving Sepsis Campaign guidelines for management of severe sepsis and septic shock. Intensive Care Med. 2004 Apr;30(4):536-55. doi: 10.1007/s00134-004-2210-z. Epub 2004 Mar 3.
Reference Type
BACKGROUND
Dellinger RP, Levy MM, Carlet JM, Bion J, Parker MM, Jaeschke R, Reinhart K, Angus DC, Brun-Buisson C, Beale R, Calandra T, Dhainaut JF, Gerlach H, Harvey M, Marini JJ, Marshall J, Ranieri M, Ramsay G, Sevransky J, Thompson BT, Townsend S, Vender JS, Zimmerman JL, Vincent JL; International Surviving Sepsis Campaign Guidelines Committee; American Association of Critical-Care Nurses; American College of Chest Physicians; American College of Emergency Physicians; Canadian Critical Care Society; European Society of Clinical Microbiology and Infectious Diseases; European Society of Intensive Care Medicine; European Respiratory Society; International Sepsis Forum; Japanese Association for Acute Medicine; Japanese Society of Intensive Care Medicine; Society of Critical Care Medicine; Society of Hospital Medicine; Surgical Infection Society; World Federation of Societies of Intensive and Critical Care Medicine. Surviving Sepsis Campaign: international guidelines for management of severe sepsis and septic shock: 2008. Crit Care Med. 2008 Jan;36(1):296-327. doi: 10.1097/01.CCM.0000298158.12101.41.
Reference Type
BACKGROUND
Dellinger RP, Levy MM, Carlet JM, Bion J, Parker MM, Jaeschke R, Reinhart K, Angus DC, Brun-Buisson C, Beale R, Calandra T, Dhainaut JF, Gerlach H, Harvey M, Marini JJ, Marshall J, Ranieri M, Ramsay G, Sevransky J, Thompson BT, Townsend S, Vender JS, Zimmerman JL, Vincent JL. Surviving Sepsis Campaign: international guidelines for management of severe sepsis and septic shock: 2008. Intensive Care Med. 2008 Jan;34(1):17-60. doi: 10.1007/s00134-007-0934-2. Epub 2007 Dec 4.
Reference Type
BACKGROUND
Dellinger RP, Levy MM, Rhodes A, Annane D, Gerlach H, Opal SM, Sevransky JE, Sprung CL, Douglas IS, Jaeschke R, Osborn TM, Nunnally ME, Townsend SR, Reinhart K, Kleinpell RM, Angus DC, Deutschman CS, Machado FR, Rubenfeld GD, Webb S, Beale RJ, Vincent JL, Moreno R; Surviving Sepsis Campaign Guidelines Committee including The Pediatric Subgroup. Surviving Sepsis Campaign: international guidelines for management of severe sepsis and septic shock, 2012. Intensive Care Med. 2013 Feb;39(2):165-228. doi: 10.1007/s00134-012-2769-8. Epub 2013 Jan 30.
Reference Type
BACKGROUND
Dellinger RP, Levy MM, Rhodes A, Annane D, Gerlach H, Opal SM, Sevransky JE, Sprung CL, Douglas IS, Jaeschke R, Osborn TM, Nunnally ME, Townsend SR, Reinhart K, Kleinpell RM, Angus DC, Deutschman CS, Machado FR, Rubenfeld GD, Webb SA, Beale RJ, Vincent JL, Moreno R; Surviving Sepsis Campaign Guidelines Committee including the Pediatric Subgroup. Surviving sepsis campaign: international guidelines for management of severe sepsis and septic shock: 2012. Crit Care Med. 2013 Feb;41(2):580-637. doi: 10.1097/CCM.0b013e31827e83af.
Reference Type
BACKGROUND
Levy MM, Dellinger RP, Townsend SR, Linde-Zwirble WT, Marshall JC, Bion J, Schorr C, Artigas A, Ramsay G, Beale R, Parker MM, Gerlach H, Reinhart K, Silva E, Harvey M, Regan S, Angus DC; Surviving Sepsis Campaign. The Surviving Sepsis Campaign: results of an international guideline-based performance improvement program targeting severe sepsis. Crit Care Med. 2010 Feb;38(2):367-74. doi: 10.1097/CCM.0b013e3181cb0cdc.
Reference Type
BACKGROUND
Levy MM, Rhodes A, Phillips GS, Townsend SR, Schorr CA, Beale R, Osborn T, Lemeshow S, Chiche JD, Artigas A, Dellinger RP. Surviving Sepsis Campaign: association between performance metrics and outcomes in a 7.5-year study. Crit Care Med. 2015 Jan;43(1):3-12. doi: 10.1097/CCM.0000000000000723.
Reference Type
BACKGROUND
Levy MM, Pronovost PJ, Dellinger RP, Townsend S, Resar RK, Clemmer TP, Ramsay G. Sepsis change bundles: converting guidelines into meaningful change in behavior and clinical outcome. Crit Care Med. 2004 Nov;32(11 Suppl):S595-7. doi: 10.1097/01.ccm.0000147016.53607.c4. No abstract available.
Reference Type
BACKGROUND
Damiani E, Donati A, Serafini G, Rinaldi L, Adrario E, Pelaia P, Busani S, Girardis M. Effect of performance improvement programs on compliance with sepsis bundles and mortality: a systematic review and meta-analysis of observational studies. PLoS One. 2015 May 6;10(5):e0125827. doi: 10.1371/journal.pone.0125827. eCollection 2015.
Reference Type
BACKGROUND
Rhodes A, Phillips G, Beale R, Cecconi M, Chiche JD, De Backer D, Divatia J, Du B, Evans L, Ferrer R, Girardis M, Koulenti D, Machado F, Simpson SQ, Tan CC, Wittebole X, Levy M. The Surviving Sepsis Campaign bundles and outcome: results from the International Multicentre Prevalence Study on Sepsis (the IMPreSS study). Intensive Care Med. 2015 Sep;41(9):1620-8. doi: 10.1007/s00134-015-3906-y. Epub 2015 Jun 25.
Reference Type
BACKGROUND
Rhodes A, Evans LE, Alhazzani W, Levy MM, Antonelli M, Ferrer R, Kumar A, Sevransky JE, Sprung CL, Nunnally ME, Rochwerg B, Rubenfeld GD, Angus DC, Annane D, Beale RJ, Bellinghan GJ, Bernard GR, Chiche JD, Coopersmith C, De Backer DP, French CJ, Fujishima S, Gerlach H, Hidalgo JL, Hollenberg SM, Jones AE, Karnad DR, Kleinpell RM, Koh Y, Lisboa TC, Machado FR, Marini JJ, Marshall JC, Mazuski JE, McIntyre LA, McLean AS, Mehta S, Moreno RP, Myburgh J, Navalesi P, Nishida O, Osborn TM, Perner A, Plunkett CM, Ranieri M, Schorr CA, Seckel MA, Seymour CW, Shieh L, Shukri KA, Simpson SQ, Singer M, Thompson BT, Townsend SR, Van der Poll T, Vincent JL, Wiersinga WJ, Zimmerman JL, Dellinger RP. Surviving Sepsis Campaign: International Guidelines for Management of Sepsis and Septic Shock: 2016. Crit Care Med. 2017 Mar;45(3):486-552. doi: 10.1097/CCM.0000000000002255.
Reference Type
BACKGROUND
Rhodes A, Evans LE, Alhazzani W, Levy MM, Antonelli M, Ferrer R, Kumar A, Sevransky JE, Sprung CL, Nunnally ME, Rochwerg B, Rubenfeld GD, Angus DC, Annane D, Beale RJ, Bellinghan GJ, Bernard GR, Chiche JD, Coopersmith C, De Backer DP, French CJ, Fujishima S, Gerlach H, Hidalgo JL, Hollenberg SM, Jones AE, Karnad DR, Kleinpell RM, Koh Y, Lisboa TC, Machado FR, Marini JJ, Marshall JC, Mazuski JE, McIntyre LA, McLean AS, Mehta S, Moreno RP, Myburgh J, Navalesi P, Nishida O, Osborn TM, Perner A, Plunkett CM, Ranieri M, Schorr CA, Seckel MA, Seymour CW, Shieh L, Shukri KA, Simpson SQ, Singer M, Thompson BT, Townsend SR, Van der Poll T, Vincent JL, Wiersinga WJ, Zimmerman JL, Dellinger RP. Surviving Sepsis Campaign: International Guidelines for Management of Sepsis and Septic Shock: 2016. Intensive Care Med. 2017 Mar;43(3):304-377. doi: 10.1007/s00134-017-4683-6. Epub 2017 Jan 18.
Reference Type
BACKGROUND
Seymour CW, Gesten F, Prescott HC, Friedrich ME, Iwashyna TJ, Phillips GS, Lemeshow S, Osborn T, Terry KM, Levy MM. Time to Treatment and Mortality during Mandated Emergency Care for Sepsis. N Engl J Med. 2017 Jun 8;376(23):2235-2244. doi: 10.1056/NEJMoa1703058. Epub 2017 May 21.
Reference Type
BACKGROUND
Liu VX, Morehouse JW, Marelich GP, Soule J, Russell T, Skeath M, Adams C, Escobar GJ, Whippy A. Multicenter Implementation of a Treatment Bundle for Patients with Sepsis and Intermediate Lactate Values. Am J Respir Crit Care Med. 2016 Jun 1;193(11):1264-70. doi: 10.1164/rccm.201507-1489OC.
Reference Type
BACKGROUND
Levy MM, Evans LE, Rhodes A. The Surviving Sepsis Campaign Bundle: 2018 update. Intensive Care Med. 2018 Jun;44(6):925-928. doi: 10.1007/s00134-018-5085-0. Epub 2018 Apr 19. No abstract available.
Reference Type
BACKGROUND
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
3364
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.
Gender-based Differences in the Outcome of the Treatment of Persistent Septic Shock With Hydrocortisone
NCT06537180
COMPLETED
COrporeal Compression at the ONset of Severe Sepsis and Septic Shock
NCT02656654
COMPLETED
NA
Hydrocortisone for Prevention of Septic Shock
NCT00670254
COMPLETED
PHASE3
Early Lactate Clearance Rate in Sepsis
NCT04192279
UNKNOWN
Disseminated Intravascular Coagulation (DIC) Score and Organ Dysfunction in Septic Shock Patients
NCT06363149
RECRUITING
Severe Sepsis/Septic Shock on Admission to the General Surgical ICU
NCT01363635
UNKNOWN
Comparison of Radial and Femoral Artery Site Invasive Blood Pressure Measurement in Septic Shock Patients
NCT03475667
COMPLETED
Metabolic Cluster Analysis in Septic Shock Patients
NCT06500156
RECRUITING
Study on the Construction and Application of Early Warning Model of Sepsis in Critically Ill Patients
NCT06904001
ENROLLING_BY_INVITATION
Assessment of Fluid Responsiveness in Septic Shock Patients, Can End-tidal co2 Measurement Help?
NCT05557461
UNKNOWN
German Lactat Clearance in Severe Sepsis
NCT01929772
COMPLETED
Resuscitation Strategies in Septic Shock
NCT02150512
UNKNOWN
NA
Effects of Stress Doses of Hydrocortisone on Coagulation Dysfunction in Patients With Septic Shock
NCT02114710
COMPLETED
PHASE3
Microcirculation Guided Therapy Versus "Standard Treatment" of Severe Sepsis
NCT00484133
UNKNOWN
PHASE4
Fluid Overload Quantification in Septic Shock
NCT04114162
COMPLETED
Ventriculo-arterial Coupling and Myocardial Work in Sepsis and Septic Shock
NCT06853574
NOT_YET_RECRUITING
NA
Effects of Hydrocortison Treatment on Angiotensin II and Angiotensin II Receptors in Patients With Septic Shock
NCT04647552
COMPLETED
Observational Study About the Use of Perfusion Index to Use Vasopressor in Sepsis
NCT06860438
RECRUITING
Outcome of Using Hydrocortisone in Early Treatment of Pediatric Septic Shock
NCT07313670
NOT_YET_RECRUITING
NA
Outcomes of Severe Sepsis Patients in Surgical Intensive Care Units
NCT01919138
COMPLETED
Effect of Dynamic Arterial Elastance and Assisted Fluid Management Software Guided Resuscitation in Septic Shock: Pilot Study
NCT06937918
RECRUITING
NA
The Application of SERS and Metabolomics in Sepsis
NCT02213237
UNKNOWN
ExtraCorporeal Membrane Oxygenation in the Therapy for REfractory Septic Shock With Cardiac Function Under Estimated
NCT05184296
RECRUITING
NA
Use of Dobutamine in Patients With Sepsis and Maintained Hypoperfusion After Initial Volemic Resuscitation.
NCT05953142
NOT_YET_RECRUITING
PHASE2