Effects of Increasing Mean Arterial Pressure on Renal Function in Patients With Shock and With Elevated Central Venous Pressure
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: increase of mean arterial pressure at 65-70 mmHg, increase of mean arterial pressure at 80-85 mmHg.
- Who it may be relevant to
- Registry conditions: Shock. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effects of Increasing Mean Arterial Pressure on Renal Function in Patients With Shock and With Elevated Central Venous Pressure : a Pilot Study for the Individualization of Mean Arterial Pressure
Overview
The purpose of this study is to assess the effect of a higher mean arterial pressure on renal function for patients with shock and elevated central venous pressure.
Detailed description
Current recommandation for mean arterial pressure (MAP) target is 65 mmHg for septic shock, but optimal target to prevent acute renal failure (ARF) remains unknown.
High central venous pressure (CVP) can lead to acute renal failure through venous congestion , and is associated with acute renal failure in intensive care unit.
A decrease of renal perfusion pressure, defined by MAP - CVP, has been shown to be associated with risk of acute renal failure.
The main objective of this trial is to evaluate if an optimisation of renal perfusion pressure, by a higher MAP when CVP is high (≥ 12 cmH2O), can improve renal function.
In this interventional monocenter trial, each patient will be evaluated during 2 consecutive periods of 6 hours, with a temporary MAP target
* Target at 65-70mmHg during 6 hours * Target at 80-85mmHg during 6 hours
Patients will be randomized into two groups to define the order of targets. There will be a stratification on previous arterial hypertension. Renal function will be measured at the end of each period.
Interventions
- Procedure increase of mean arterial pressure at 65-70 mmHg
Increase of mean arterial pressure at 65-70 mmHg (with catecholamines or volemic expansion at the discretion of the clinician) - Procedure increase of mean arterial pressure at 80-85 mmHg
Increase of mean arterial pressure at 80-85mmHg (with catecholamines or volemic expansion at the discretion of the clinician).
Primary outcome measures
- Changes of creatinine clearance [Time frame: At 6 hours and at 12 hours]
Secondary outcome measures (12)
- Changes of renal resistive index [Time frame: At 6 hours and 12 hours]
- Co-morbidities [Time frame: At inclusion.]
- Arterial hypertension treatment [Time frame: At inclusion.]
- Introduction time of norepinephrine [Time frame: At inclusion]
- Norepinephrine dose [Time frame: At inclusion, then every hours up to hour 12]
- Amount of fluids (unit = L ) [Time frame: At 6 hours and 12 hours]
- Quantity of nephrotoxic drugs [Time frame: At inclusion, at 6 hours and 12 hours]
- Intra-vesical pression [Time frame: At inclusion then every hour up to 12 hours.]
- Number of day with supportive care in intensive care unit (cathecolamines, renal replacement therapy, mechanical ventilation, extracorporeal membrane oxygenation) [Time frame: Day 90]
- Number of days in intensive care unit [Time frame: Day 90]
- Number of days in hospital [Time frame: Day 90]
- Survival at day 90 [Time frame: Day 90]
Eligibility criteria
Inclusion criteria
- Adult patients (≥ 18 years old )
- Arterial hypotension requiring the etablishment of catecholamines
- Norepinephrine dose ⩾ 0.1µg/kg/min at the inclusion
- High central venous pressure ≥ 12mmHg
- Cardiac output monitoring (PICCO or Swan Ganz)
Exclusion criteria
- Anuria
- Patient with an emergency indication of renal replacement therapy (severe hyperkalemia, severe metabolical acidosis with pH <7.15, acute pulmonary edema due to fluid overload resulting in severe hypoxemia, serum urea concentration > 40 mmol/l)
- Pregnant, lactating or parturient woman
- Patient deprived of liberty by judicial or administrative decision
- Patient with psychiatric compulsory care
- Patient subject to legal protection measures
- Patients with do-no-reanimate order or withdrawal of life sustaining support
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Open label
- Primary purpose
- Other
Study locations
France · 2 centers
- Angers University Hospital — Angers
- Vendée Hospital — La Roche-sur-Yon
Identifiers
NCT: NCT05655065 · 49RC22_0293