The Effects of Blood Pressure on Renal Function and Oxygenation in Septic Shock
NCT ID: NCT02453425
Last Updated: 2017-04-25
Study Results
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.
COMPLETED
NA
8 participants
INTERVENTIONAL
2011-05-31
2017-03-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Relation Between Mean Arterial Pressure and Renal Resistive Index in the Early Phase of Septic Shock
NCT04281277
Assessment of Two Levels of Arterial Pressure on Survival in Patients With Septic Shock
NCT01149278
Microcirculation After MAP Increase in Septic Shock Patients With Previous Hypertension
NCT02519699
The Effect of Vasopressor Therapy on Renal Perfusion in Septic Shock
NCT06234592
Personalized Mean Arterial Pressure Management on Renal Function During Septic Shock
NCT01473498
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
The purpose of this study is to chart the renal perfusion, oxygenation and function, and moreover to evaluate renal effects of 3 different levels of mean arterial pressure, in early phase of septic shock.
Patients will be included within the first 24 hrs after admission to the ICU diagnosed with septic shock. The patients will be sedated, mechanically ventilated and in need for norepinephrine for adequate blood pressure levels.
After 60 mins of steady state at MAP 75 mmHg, norepinephrine will be adjusted achieve MAP of 60 and 90 mmHg respectively, MAP being held at each level for 30 mins. At the end of each 30 mins period, central and renal hemodynamics will be measured, blood and urine samples will be collected.
Central hemodynamics will be measured by, and blood samples collected via a pulmonary catheter and an arterial line.
Renal hemodynamics will be measured using a renal vein catheter for retrograde thermodilution giving at hand renal blood flow (RBF), renal vein blood samples and urine collection provides extraction of Cr-EDTA for filtration fraction (FF) and glomerular filtration rate (GFR), renal oxygen consumption, and renal oxygen extraction as a measure of balance between renal oxygen delivery and consumption.
Via renal vein catheterisation and retrograde thermodilution, the study group have the unique possibility to actually evaluate renal blood flow, renal oxygenation and renal function in humans in vivo.
After finishing the data collection, analysis will be made to answer the question: which MAP is the most optimal concerning RBF, GFR and renal oxygenation in patients with septic shock?
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
PREVENTION
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
60 mmHg
Norepinephrine adjusted to reach MAP 60 mmHg
MAP 60 mmHg
Norepinephrine adjusted to reach MAP 60 mmHg
75 mmHg
Norepinephrine adjusted to reach MAP 75 mmHg
MAP 75 mmHg
Norepinephrine adjusted to reach MAP 75 mmHg
90 mmHg
Norepinephrine adjusted to reach MAP 90 mmHg
MAP 90 mmHg
Norepinephrine adjusted to reach MAP 90 mmHg
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
MAP 60 mmHg
Norepinephrine adjusted to reach MAP 60 mmHg
MAP 75 mmHg
Norepinephrine adjusted to reach MAP 75 mmHg
MAP 90 mmHg
Norepinephrine adjusted to reach MAP 90 mmHg
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* normovolemic
* norepinephrine
* intubated/ventilated
* normal s-creatinine according to local laboratory regards.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Sahlgrenska University Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Jenny Skytte Larsson
MD
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Sven-Erik Ricksten, Professor
Role: STUDY_CHAIR
Sahlgrenska University Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Sahlgrenska University Hospital, dpt of anesthesiology and intensive care
Gothenburg, VGR, Sweden
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Sepsis-studien
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.