Actively Recruiting
Effects of Increasing Mean Arterial Pressure on Renal Function in Patients With Shock and Elevated Central Venous Pressure: A Pilot Study to Individualize Mean Arterial Pressure
Led by University Hospital, Angers · Updated on 2026-04-06
30
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effect of increasing mean arterial pressure (MAP) on kidney function in adults with shock who also have high central venous pressure (CVP). The study aims to determine if raising MAP above the current standard target can better prevent acute kidney problems by improving renal perfusion pressure, which is the difference between MAP and CVP. This is a pilot interventional trial focusing on patients with elevated CVP of 12 cmH2O or higher who require catecholamine treatment for low blood pressure. Participants will undergo two consecutive 6-hour treatment periods with different MAP targets. One period targets a MAP of 65-70 mmHg, and the other targets a higher MAP of 80-85 mmHg. Patients are randomly assigned to the order of these targets. The treatment to achieve these MAP goals includes increasing catecholamines and/or fluid volume, guided by the clinician following standard recommendations. The study includes monitoring cardiac output using PICCO or Swan Ganz devices. During the study, kidney function will be assessed by measuring creatinine clearance at the end of each 6-hour period. Additional evaluations include renal resistive index, cardiac function measures, fluid amounts, medication doses, and other laboratory tests at set intervals. Researchers will also record adverse events and monitor clinical outcomes up to 90 days, including survival and duration of intensive care or hospital stay. The total participation involves close monitoring over 12 hours with follow-up data collected at 90 days.
CONDITIONS
Brief Title
Effects of Increasing Mean Arterial Pressure on Renal Function in Patients With Shock and With Elevated Central Venous Pressure
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult patients aged 18 years or older
- Arterial hypotension requiring catecholamine treatment
- Norepinephrine dose of at least 0.1 µg/kg/min at inclusion
- Central venous pressure of 12 mmHg or higher
- Cardiac output monitoring by PICCO or Swan Ganz device
You will not qualify if you...
- Anuria (no urine output)
- Emergency need for renal replacement therapy due to severe conditions
- Pregnant, breastfeeding, or recently gave birth
- Patients legally deprived of liberty
- Patients under compulsory psychiatric care
- Patients under legal protection measures
- Patients with do-not-resuscitate orders or withdrawal of life-sustaining treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 hours
Participants undergo two consecutive 6-hour periods with different mean arterial pressure targets to evaluate effects on renal function. The order of targets is randomized: one period with a MAP target of 65-70 mmHg and one period with a MAP target of 80-85 mmHg.
Continuous monitoring during 2 periods of 6 hours each
Trial Site Locations
Total: 2 locations
1
Angers University Hospital
Angers, France
Actively Recruiting
2
Vendée Hospital
La Roche-sur-Yon, France
Actively Recruiting
Research Team
N
Nicolas FAGE, MD
I
Ines ZIRIAT, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
OTHER
Number of Arms
2
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