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
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Recruitment Status
NOT_YET_RECRUITING
Clinical Phase
PHASE4
Total Enrollment
318 participants
Study Classification
INTERVENTIONAL
Study Start Date
2025-12-20
Study Completion Date
2028-12-30
Brief Summary
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The goal of this randomized clinical trial is to evaluate whether balanced gelatin solution is more effective and safe than balanced crystalloid solution for perioperative fluid management in adults with sepsis undergoing emergency abdominal surgery. Sepsis often causes severe fluid loss from the bloodstream into tissues, leading to low blood pressure, impaired organ function, and the need for urgent fluid resuscitation. Balanced gelatin, a colloid solution, may help maintain intravascular volume more effectively than crystalloid alone.
In this study, participants are randomly assigned in a 1:1 ratio to receive either balanced gelatin or Ringer's acetate during surgery and in the first 24 hours afterward. All patients receive standardized anesthesia care, goal-directed fluid therapy, and protocolized use of vasoactive drugs. The main questions the study aims to answer are:
* Does balanced gelatin reduce positive fluid balance within 24 hours after surgery?
* Does it improve hemodynamic stability during the early postoperative period?
* What effects does balanced gelatin have on kidney function, microcirculation, postoperative recovery, and other clinical outcomes?
Participants will be followed throughout hospitalization and contacted again on postoperative day 28 and day 90 to assess survival, complications, and health-related quality of life. The trial is double-blind, meaning that patients, clinicians, and outcome assessors do not know which fluid is being used. An independent Data and Safety Monitoring Board will oversee patient safety during the study.
The findings of this trial are expected to provide important evidence to guide perioperative fluid resuscitation strategies for septic patients undergoing emergency surgery.
In this study, participants are randomly assigned in a 1:1 ratio to receive either balanced gelatin or Ringer's acetate during surgery and in the first 24 hours afterward. All patients receive standardized anesthesia care, goal-directed fluid therapy, and protocolized use of vasoactive drugs. The main questions the study aims to answer are:
* Does balanced gelatin reduce positive fluid balance within 24 hours after surgery?
* Does it improve hemodynamic stability during the early postoperative period?
* What effects does balanced gelatin have on kidney function, microcirculation, postoperative recovery, and other clinical outcomes?
Participants will be followed throughout hospitalization and contacted again on postoperative day 28 and day 90 to assess survival, complications, and health-related quality of life. The trial is double-blind, meaning that patients, clinicians, and outcome assessors do not know which fluid is being used. An independent Data and Safety Monitoring Board will oversee patient safety during the study.
The findings of this trial are expected to provide important evidence to guide perioperative fluid resuscitation strategies for septic patients undergoing emergency surgery.
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Detailed Description
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Study Background Sepsis is a life-threatening syndrome caused by a dysregulated host response to severe infection, which can rapidly progress to septic shock, multiple organ dysfunction, and death.Despite advances in recognition and treatment in recent years, sepsis remains a major global health challenge, with overall mortality rates still ranging from 18% to 30%.Pathophysiologically, sepsis is characterized by increased capillary permeability and vasodilation, resulting in substantial fluid extravasation into the interstitial space, tissue edema, and intravascular volume depletion. These changes lead to inadequate tissue perfusion, impaired oxygen delivery, and ultimately organ dysfunction. Therefore, timely and appropriate fluid resuscitation remains one of the most fundamental and essential components of sepsis management. Individualized, goal-directed fluid therapy aims to improve systemic perfusion while minimizing the risks associated with fluid overload.
In 2001, Rivers et al. introduced the concept of early goal-directed therapy (EGDT), demonstrating significant mortality reduction (30.5% vs 45%) in patients with severe sepsis and septic shock.This finding prompted widespread adoption of early aggressive fluid resuscitation. However, three large multicenter trials published between 2014 and 2015 (ARISE, ProCESS, and ProMISe) later found no significant mortality differences between EGDT and usual care (approximately 18-25%).These results suggested that with improvements in routine clinical practice, contemporary usual care may already include adequate hemodynamic optimization.
Based on this evidence, the 2016 Surviving Sepsis Campaign (SSC) guidelines recommended administration of at least 30 mL/kg of crystalloid fluid within the first 3 hours for patients with sepsis-induced hypoperfusion, followed by hemodynamic-guided adjustment.Because many participants in these large trials had already received similar volumes before randomization, this dosage became associated with favorable outcomes. The 2021 SSC guideline retained this recommendation, though downgraded from a "strong" to a "weak" recommendation in the absence of new high-quality evidence.This highlights persistent uncertainty and the need for further research on optimal fluid type and strategy in sepsis resuscitation.
Increasing attention has been paid to microcirculation in recent years. While macrocirculatory parameters such as blood pressure may normalize after resuscitation, this does not necessarily indicate restoration of tissue-level perfusion.Persistent microcirculatory dysfunction may contribute to inadequate oxygen delivery and delayed organ recovery. Understanding how different fluid therapies influence both macro- and microcirculation is therefore crucial for optimizing outcomes.
Currently used resuscitation fluids include crystalloids and colloids. Crystalloids rapidly redistribute into the interstitial space and may exacerbate tissue edema-particularly in sepsis where capillary permeability is increased-potentially impairing microcirculatory flow.Colloids contain larger molecules that remain intravascular for longer periods, generating oncotic pressure and maintaining circulating volume more effectively, which may theoretically support microcirculatory perfusion and oxygen delivery. Clinically used colloids include albumin, hydroxyethyl starch (HES), and gelatin. Albumin is effective but costly and limited in availability. HES has fallen out of favor due to its association with kidney injury and increased mortality in sepsis.Gelatin, derived from bovine collagen hydrolysates, is now the only artificial colloid still recommended by guidelines for hypovolemia in sepsis patients.Nevertheless, high-quality randomized controlled evidence comparing gelatin with crystalloids in sepsis remains insufficient.
Based on this background, the present study focuses on balanced gelatin solution-a compound solution containing 4% succinylated gelatin in a balanced crystalloid carrier. We hypothesize that, compared with balanced crystalloid alone, balanced gelatin may better support hemodynamic stability through its colloid osmotic effect, more effectively correct fluid imbalance, improve microcirculatory perfusion, promote organ function recovery, and ultimately improve clinical outcomes. This randomized controlled trial is designed to rigorously test this hypothesis.
Patient and Public Involvement (PPIE)
During the protocol development stage, this study incorporated Patient and Public Involvement (PPIE). Three public contributors without medical backgrounds were invited to review the full protocol and informed consent form prior to study initiation. They provided feedback from the perspective of typical patients and family members. The main areas of concern included:
* The need for more accessible and patient-friendly language when describing the study background and objectives.
* Difficulty understanding the double-blind design, with recommendations to use analogies or simplified explanations.
* High concern regarding safety issues, including allergic reactions, kidney injury, and fluid-related adverse events, and a desire for clear descriptions of emergency procedures and contact information.
* Interest in treatment stability, postoperative supportive care needs, long-term complications, and follow-up arrangements.
* Questions regarding treatment-related costs, the exploratory nature of the intervention, and whether future protocol optimization is planned.
* Expectation that overall study results will be shared with participants after study completion.
Based on this feedback, the research team has revised and optimized the protocol background, the explanation of "double-blind" in the informed consent form, the safety management procedures, the follow-up plan, and the approach for disseminating study results. These adjustments aim to enhance the clarity, acceptability, and overall engagement of patient participants.
Study Objectives Primary Objective To evaluate the effectiveness of balanced gelatin solution in perioperative fluid management for septic patients undergoing emergency non-cardiac surgery, with emphasis on:reducing perioperative positive fluid balance；promoting hemodynamic stability；improving microcirculatory perfusion；and supporting organ function recovery and clinical outcomes.
Secondary Objective To assess the safety of balanced gelatin solution in this population, focusing on its effects on kidney function, coagulation status, and common postoperative complications.
Study Design This is a prospective, multicenter, randomized, double-blind, controlled clinical trial with an adaptive design incorporating sample size re-estimation. An initial sample size of 318 patients (159 per group) will be recruited, with an interim analysis after enrollment of 50% of participants to reassess the required sample size. Patients are randomized in a 1:1 ratio to receive either balanced gelatin or crystalloid solution (Ringer's acetate). Randomization is stratified by baseline blood lactate level (≤ 4 mmol/L vs \> 4 mmol/L) using a central dynamic allocation system to ensure balance between groups.
Population Eligible patients are adults (≥18 years) with sepsis (per Sepsis-3 criteria) due to abdominal infection requiring emergency surgery. Inclusion requires a SOFA score ≥2 and lactate \>2 mmol/L. Key exclusions include prior colloid use within 24 hours, expected death within 48 hours, advanced heart failure, severe ARDS, pre-existing renal replacement therapy, severe coagulopathy, liver failure, or allergy to gelatin.
Interventions All participants receive standardized anesthesia care. Intraoperative fluid therapy follows a goal-directed protocol guided by stroke volume monitoring. After randomization, patients in the intervention group receive balanced gelatin solution as the resuscitation fluid (maximum dose 30 mL/kg within 24 hours), while controls receive Ringer's acetate only. Both groups receive a baseline infusion of Ringer's acetate at 3 mL/kg/h during anesthesia. Vasoactive drugs are used according to predefined hemodynamic triggers. Postoperatively, the assigned fluid regimen is continued for 24 hours, after which fluid management follows routine clinical practice.
Endpoints
Primary endpoints include:
Cumulative fluid balance within 24 hours after surgery. Proportion of patients achieving hemodynamic stability within 24 hours. Secondary endpoints include kidney function, SOFA score dynamics, lactate clearance, need for vasopressors or renal replacement therapy, postoperative complications, ICU and hospital length of stay, and all-cause mortality at 28 and 90 days. Safety endpoints include pulmonary edema, arrhythmias, and acute kidney injury.
Follow-up Patients will be followed during hospitalization and by structured telephone interviews at day 28 and day 90. Follow-up assessments include survival, complications, and health-related quality of life using the EQ-5D-5L questionnaire.
Blinding and Oversight The study is double-blind: patients, treating clinicians, outcome assessors, and statisticians remain unaware of group allocation. Randomization and drug packaging are handled by independent, unblinded coordinators. Emergency unblinding is permitted only for patient safety. An independent Data and Safety Monitoring Board (DSMB) will oversee trial conduct and review adverse events.
Significance By directly comparing balanced gelatin with crystalloids in septic patients undergoing emergency abdominal surgery, this trial will provide critical evidence regarding the efficacy and safety of gelatin-based fluid resuscitation. Results are expected to inform perioperative fluid management strategies and contribute to guideline development in the management of sepsis.
In 2001, Rivers et al. introduced the concept of early goal-directed therapy (EGDT), demonstrating significant mortality reduction (30.5% vs 45%) in patients with severe sepsis and septic shock.This finding prompted widespread adoption of early aggressive fluid resuscitation. However, three large multicenter trials published between 2014 and 2015 (ARISE, ProCESS, and ProMISe) later found no significant mortality differences between EGDT and usual care (approximately 18-25%).These results suggested that with improvements in routine clinical practice, contemporary usual care may already include adequate hemodynamic optimization.
Based on this evidence, the 2016 Surviving Sepsis Campaign (SSC) guidelines recommended administration of at least 30 mL/kg of crystalloid fluid within the first 3 hours for patients with sepsis-induced hypoperfusion, followed by hemodynamic-guided adjustment.Because many participants in these large trials had already received similar volumes before randomization, this dosage became associated with favorable outcomes. The 2021 SSC guideline retained this recommendation, though downgraded from a "strong" to a "weak" recommendation in the absence of new high-quality evidence.This highlights persistent uncertainty and the need for further research on optimal fluid type and strategy in sepsis resuscitation.
Increasing attention has been paid to microcirculation in recent years. While macrocirculatory parameters such as blood pressure may normalize after resuscitation, this does not necessarily indicate restoration of tissue-level perfusion.Persistent microcirculatory dysfunction may contribute to inadequate oxygen delivery and delayed organ recovery. Understanding how different fluid therapies influence both macro- and microcirculation is therefore crucial for optimizing outcomes.
Currently used resuscitation fluids include crystalloids and colloids. Crystalloids rapidly redistribute into the interstitial space and may exacerbate tissue edema-particularly in sepsis where capillary permeability is increased-potentially impairing microcirculatory flow.Colloids contain larger molecules that remain intravascular for longer periods, generating oncotic pressure and maintaining circulating volume more effectively, which may theoretically support microcirculatory perfusion and oxygen delivery. Clinically used colloids include albumin, hydroxyethyl starch (HES), and gelatin. Albumin is effective but costly and limited in availability. HES has fallen out of favor due to its association with kidney injury and increased mortality in sepsis.Gelatin, derived from bovine collagen hydrolysates, is now the only artificial colloid still recommended by guidelines for hypovolemia in sepsis patients.Nevertheless, high-quality randomized controlled evidence comparing gelatin with crystalloids in sepsis remains insufficient.
Based on this background, the present study focuses on balanced gelatin solution-a compound solution containing 4% succinylated gelatin in a balanced crystalloid carrier. We hypothesize that, compared with balanced crystalloid alone, balanced gelatin may better support hemodynamic stability through its colloid osmotic effect, more effectively correct fluid imbalance, improve microcirculatory perfusion, promote organ function recovery, and ultimately improve clinical outcomes. This randomized controlled trial is designed to rigorously test this hypothesis.
Patient and Public Involvement (PPIE)
During the protocol development stage, this study incorporated Patient and Public Involvement (PPIE). Three public contributors without medical backgrounds were invited to review the full protocol and informed consent form prior to study initiation. They provided feedback from the perspective of typical patients and family members. The main areas of concern included:
* The need for more accessible and patient-friendly language when describing the study background and objectives.
* Difficulty understanding the double-blind design, with recommendations to use analogies or simplified explanations.
* High concern regarding safety issues, including allergic reactions, kidney injury, and fluid-related adverse events, and a desire for clear descriptions of emergency procedures and contact information.
* Interest in treatment stability, postoperative supportive care needs, long-term complications, and follow-up arrangements.
* Questions regarding treatment-related costs, the exploratory nature of the intervention, and whether future protocol optimization is planned.
* Expectation that overall study results will be shared with participants after study completion.
Based on this feedback, the research team has revised and optimized the protocol background, the explanation of "double-blind" in the informed consent form, the safety management procedures, the follow-up plan, and the approach for disseminating study results. These adjustments aim to enhance the clarity, acceptability, and overall engagement of patient participants.
Study Objectives Primary Objective To evaluate the effectiveness of balanced gelatin solution in perioperative fluid management for septic patients undergoing emergency non-cardiac surgery, with emphasis on:reducing perioperative positive fluid balance；promoting hemodynamic stability；improving microcirculatory perfusion；and supporting organ function recovery and clinical outcomes.
Secondary Objective To assess the safety of balanced gelatin solution in this population, focusing on its effects on kidney function, coagulation status, and common postoperative complications.
Study Design This is a prospective, multicenter, randomized, double-blind, controlled clinical trial with an adaptive design incorporating sample size re-estimation. An initial sample size of 318 patients (159 per group) will be recruited, with an interim analysis after enrollment of 50% of participants to reassess the required sample size. Patients are randomized in a 1:1 ratio to receive either balanced gelatin or crystalloid solution (Ringer's acetate). Randomization is stratified by baseline blood lactate level (≤ 4 mmol/L vs \> 4 mmol/L) using a central dynamic allocation system to ensure balance between groups.
Population Eligible patients are adults (≥18 years) with sepsis (per Sepsis-3 criteria) due to abdominal infection requiring emergency surgery. Inclusion requires a SOFA score ≥2 and lactate \>2 mmol/L. Key exclusions include prior colloid use within 24 hours, expected death within 48 hours, advanced heart failure, severe ARDS, pre-existing renal replacement therapy, severe coagulopathy, liver failure, or allergy to gelatin.
Interventions All participants receive standardized anesthesia care. Intraoperative fluid therapy follows a goal-directed protocol guided by stroke volume monitoring. After randomization, patients in the intervention group receive balanced gelatin solution as the resuscitation fluid (maximum dose 30 mL/kg within 24 hours), while controls receive Ringer's acetate only. Both groups receive a baseline infusion of Ringer's acetate at 3 mL/kg/h during anesthesia. Vasoactive drugs are used according to predefined hemodynamic triggers. Postoperatively, the assigned fluid regimen is continued for 24 hours, after which fluid management follows routine clinical practice.
Endpoints
Primary endpoints include:
Cumulative fluid balance within 24 hours after surgery. Proportion of patients achieving hemodynamic stability within 24 hours. Secondary endpoints include kidney function, SOFA score dynamics, lactate clearance, need for vasopressors or renal replacement therapy, postoperative complications, ICU and hospital length of stay, and all-cause mortality at 28 and 90 days. Safety endpoints include pulmonary edema, arrhythmias, and acute kidney injury.
Follow-up Patients will be followed during hospitalization and by structured telephone interviews at day 28 and day 90. Follow-up assessments include survival, complications, and health-related quality of life using the EQ-5D-5L questionnaire.
Blinding and Oversight The study is double-blind: patients, treating clinicians, outcome assessors, and statisticians remain unaware of group allocation. Randomization and drug packaging are handled by independent, unblinded coordinators. Emergency unblinding is permitted only for patient safety. An independent Data and Safety Monitoring Board (DSMB) will oversee trial conduct and review adverse events.
Significance By directly comparing balanced gelatin with crystalloids in septic patients undergoing emergency abdominal surgery, this trial will provide critical evidence regarding the efficacy and safety of gelatin-based fluid resuscitation. Results are expected to inform perioperative fluid management strategies and contribute to guideline development in the management of sepsis.
Conditions
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Sepsis
Intra-Abdominal Infections
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
This is a prospective, multicenter, double-blind, randomized controlled clinical trial with a parallel assignment design. Eligible patients will be randomized in a 1:1 ratio to receive either balanced gelatin solution or crystalloid solution as the primary resuscitation fluid during emergency abdominal surgery for sepsis. Randomization is stratified by baseline lactate level (≤4 vs. \>4 mmol/L) using a central dynamic allocation system.
Primary Study Purpose
TREATMENT
Blinding Strategy
QUADRUPLE
Participants
Caregivers
Investigators
Outcome Assessors
This trial uses a double-blind design. Participants, treating clinicians (care providers), investigators, and outcomes assessors are all blinded to treatment allocation. Study fluids (balanced gelatin vs. crystalloid) are packaged in identical opaque containers by an independent coordinator who is not involved in patient care or outcome assessment. Randomization and labeling are performed centrally, and only the data monitoring committee has access to unblinded allocation if required for patient safety.
Study Groups
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Balanced Gelatin Solution
Patients randomized to the balanced gelatin group will receive balanced gelatin solution (4% succinylated gelatin in a balanced crystalloid carrier) as the primary resuscitation fluid during emergency abdominal surgery for sepsis. Fluid administration follows a goal-directed protocol guided by stroke volume monitoring. The maximum total volume of balanced gelatin is limited to 30 mL/kg (ideal body weight) within the intraoperative and first 24-hour postoperative period. If the limit is reached, additional resuscitation will be performed with balanced crystalloid solution.
Group Type
EXPERIMENTAL
Balanced Gelatin Solution
Intervention Type
DRUG
Balanced gelatin solution (4% succinylated gelatin in a balanced crystalloid carrier). Administered as resuscitation fluid in patients with sepsis undergoing emergency abdominal surgery. Infusion follows a stroke volume-guided, goal-directed fluid therapy protocol. The total dose is limited to 30 mL/kg (ideal body weight) during the intraoperative period and the first 24 postoperative hours. If the maximum dose is reached, additional resuscitation is provided with balanced crystalloid solution.
Crystalloid Solution
Patients randomized to the crystalloid group will receive acetate Ringer's solution as the sole resuscitation fluid during emergency abdominal surgery for sepsis, according to the same goal-directed protocol guided by stroke volume monitoring. No gelatin solution will be administered in this group. The total volume of crystalloid infusion is not limited.
Group Type
ACTIVE_COMPARATOR
Acetate Ringer's Solution
Intervention Type
DRUG
Acetate Ringer's solution, a balanced crystalloid, administered as the sole resuscitation fluid in patients with sepsis undergoing emergency abdominal surgery. Fluid therapy follows the same stroke volume-guided, goal-directed protocol as the experimental arm. There is no upper limit for the total volume of crystalloid infusion during the intraoperative and first 24 postoperative hours.
Interventions
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Balanced Gelatin Solution
Balanced gelatin solution (4% succinylated gelatin in a balanced crystalloid carrier). Administered as resuscitation fluid in patients with sepsis undergoing emergency abdominal surgery. Infusion follows a stroke volume-guided, goal-directed fluid therapy protocol. The total dose is limited to 30 mL/kg (ideal body weight) during the intraoperative period and the first 24 postoperative hours. If the maximum dose is reached, additional resuscitation is provided with balanced crystalloid solution.
Intervention Type
DRUG
Acetate Ringer's Solution
Acetate Ringer's solution, a balanced crystalloid, administered as the sole resuscitation fluid in patients with sepsis undergoing emergency abdominal surgery. Fluid therapy follows the same stroke volume-guided, goal-directed protocol as the experimental arm. There is no upper limit for the total volume of crystalloid infusion during the intraoperative and first 24 postoperative hours.
Intervention Type
DRUG
Other Intervention Names
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Succinylated Gelatin 4%
Gelatin Infusion
Gelaspan
Balanced Crystalloid Solution
Ringer's Acetate
Eligibility Criteria
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Inclusion Criteria
* Age ≥18 years.
* Diagnosis of sepsis according to Sepsis-3 definition.
* Scheduled for emergency non-cardiac surgery under general anesthesia.
* Randomization and study intervention can be initiated before skin incision.
* Provision of written informed consent by patient or legal representative.
* Diagnosis of sepsis according to Sepsis-3 definition.
* Scheduled for emergency non-cardiac surgery under general anesthesia.
* Randomization and study intervention can be initiated before skin incision.
* Provision of written informed consent by patient or legal representative.
Exclusion Criteria
* Cardiac surgery, neurosurgery, or procedures requiring cardiopulmonary bypass.
* Severe preexisting cardiac dysfunction (ejection fraction \<30%, NYHA class IV).
* End-stage renal disease requiring chronic renal replacement therapy.
* Known severe hepatic failure (Child-Pugh C).
* Known allergy or contraindication to study fluids (gelatin solution or crystalloid solution).
* Pregnant or lactating women.
* Participation in another interventional trial within the past 30 days.
* Life expectancy \<24 hours or decision to withhold/withdraw life-sustaining treatment.
* Severe preexisting cardiac dysfunction (ejection fraction \<30%, NYHA class IV).
* End-stage renal disease requiring chronic renal replacement therapy.
* Known severe hepatic failure (Child-Pugh C).
* Known allergy or contraindication to study fluids (gelatin solution or crystalloid solution).
* Pregnant or lactating women.
* Participation in another interventional trial within the past 30 days.
* Life expectancy \<24 hours or decision to withhold/withdraw life-sustaining treatment.
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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B. Braun Medical International Trading Company Ltd.
INDUSTRY
Sponsor Role
collaborator
Shanghai Zhongshan Hospital
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Changhong Miao, MD
Role: PRINCIPAL_INVESTIGATOR
Fudan University
Locations
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The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
Site Status
Zhongda Hospital, Southeast University
Nanjing, Jiangsu, China
Site Status
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
Site Status
Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, China
Site Status
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, China
Site Status
West China Hospital of Sichuan University
Chengdu, Sichuan, China
Site Status
Tianjin Medical University General Hospital
Tianjing, Tianjing, China
Site Status
The Second Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Site Status
The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University (WMU)
Wenzhou, Zhejiang, China
Site Status
Countries
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China
Central Contacts
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Facility Contacts
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References
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BACKGROUND
Stockwell MA, Scott A, Day A, Riley B, Soni N. Colloid solutions in the critically ill. A randomised comparison of albumin and polygeline 2. Serum albumin concentration and incidences of pulmonary oedema and acute renal failure. Anaesthesia. 1992 Jan;47(1):7-9. doi: 10.1111/j.1365-2044.1992.tb01942.x.
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Gondos T, Marjanek Z, Ulakcsai Z, Szabo Z, Bogar L, Karolyi M, Gartner B, Kiss K, Havas A, Futo J. Short-term effectiveness of different volume replacement therapies in postoperative hypovolaemic patients. Eur J Anaesthesiol. 2010 Sep;27(9):794-800. doi: 10.1097/EJA.0b013e32833b3504.
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Tseng CH, Chen TT, Wu MY, Chan MC, Shih MC, Tu YK. Resuscitation fluid types in sepsis, surgical, and trauma patients: a systematic review and sequential network meta-analyses. Crit Care. 2020 Dec 14;24(1):693. doi: 10.1186/s13054-020-03419-y.
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Marx G, Schindler AW, Mosch C, Albers J, Bauer M, Gnass I, Hobohm C, Janssens U, Kluge S, Kranke P, Maurer T, Merz W, Neugebauer E, Quintel M, Senninger N, Trampisch HJ, Waydhas C, Wildenauer R, Zacharowski K, Eikermann M. Intravascular volume therapy in adults: Guidelines from the Association of the Scientific Medical Societies in Germany. Eur J Anaesthesiol. 2016 Jul;33(7):488-521. doi: 10.1097/EJA.0000000000000447. No abstract available.
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BACKGROUND
Brunkhorst FM, Engel C, Bloos F, Meier-Hellmann A, Ragaller M, Weiler N, Moerer O, Gruendling M, Oppert M, Grond S, Olthoff D, Jaschinski U, John S, Rossaint R, Welte T, Schaefer M, Kern P, Kuhnt E, Kiehntopf M, Hartog C, Natanson C, Loeffler M, Reinhart K; German Competence Network Sepsis (SepNet). Intensive insulin therapy and pentastarch resuscitation in severe sepsis. N Engl J Med. 2008 Jan 10;358(2):125-39. doi: 10.1056/NEJMoa070716.
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Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Ethics Approval No. B2025-465R
Identifier Type: OTHER
Identifier Source: secondary_id
ZSANES.B2025-465R
Identifier Type: -
Identifier Source: org_study_id
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