Clinical trial NCT01473498: Personalized Mean Arterial Pressure Management on Renal Function During Septic Shock
Official title: Personalized Haemodynamic Management of Septic Shock: Influence of Mean Arterial Pressure Level on Renal Function: Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Septic Shock
Acute Kidney Injury
Keywords: Sepsis
Acute kidney injury
Mean arterial pressure
Catecholamines
Renal doppler
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2011-11-17
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Sepsis is the most severe complication of infections. Sepsis-associated Acute kidney injury (AKI) is commonly encountered in critically ill patients and independently predicts poor outcome. Unfortunately, no drug or management strategy was able to reduce incidence of AKI. To adapt the level of mean arterial pressure according to local renal hemodynamic evaluated by renal Doppler could lead to a better renal perfusion, and then less AKI.

Detailed description: Acute Kidney Injury (AKI) is a frequent and serious complication of sepsis. Renal ischemia plays a major role in the pathophysiology of sepsis-associated AKI. There is currently no treatment to prevent or to treat AKI. It has been shown that a resistivity index (RI) greater than 0.74 of patients with septic shock could predict the occurrence of renal failure, and that increase mean arterial pressure (MAP) with norepinephrine could decrease RI. Hence, we propose to compare the frequency and the severity of the sepsis-associated AKI according to the early hemodynamic management of septic shock. Patients will be randomized in a classic group (MAP 65 mmHg) and an interventional group (MAP 85 mmHg). We can thus determine whether the level of MAP influences renal function, and whether this influence of MAP is dependent of renal perfusion assessed by renal Doppler.

Participants will be followed for the duration of hospital stay, an expected average of 4 weeks.

Primary endpoint:

-Presence and severity of sepsis-associated AKI at day 7.

Secondary endpoints:

* Acute renal failure measured by Classification AKI at day 28.
* Acute renal failure as measured by the RIFLE classification in the fourth to seventh day and 28th day.
* Use of renal replacement therapy during hospitalization in intensive care unit
* Mortality at day 28 Duration of study: Recruitment: 10 months, the patient monitoring: 28 days ± 3 days, total test duration: 11 months

Eligibility criteria: Inclusion Criteria:

* Any patient with septic shock may be included in the next 6 to 16h
* Age \> 18 years old and \<= 80 years

Exclusion Criteria:

* Chronic renal failure (Baseline serum creatinine \> 120 mmol/L)
* Chronic cardiac failure (Left ventricle ejection fraction \< 40%)
* Pregnancy
* Urinary Tract Infection
* Patients with a left ventricular dysfunction ( ventricular ejection fraction \<40%)

Primary outcomes:
measure: Acute kidney injury according to RIFLE score
timeFrame: at 7 days
Secondary outcomes:
measure: Need for renal replacement therapy
timeFrame: during hospitalization
measure: All cause mortality
timeFrame: at 28 days
Other outcomes:
Locations:
city: Kremlin Bicêtre
country: France
facility: Reanimation Chirurgicale - Hôpital Kremlin Bicêtre
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Jacques DURANTEAU, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: