Personalized Mean Arterial Pressure Management on Renal Function During Septic Shock

Condition(s) targeted: Septic Shock; Acute Kidney Injury

Intervention: Haemodynamic management (Other); Haemodynamic management (Other)

Phase: N/A

Status: Recruiting

Sponsored by: Assistance Publique - Hôpitaux de Paris

Official(s) and/or principal investigator(s):
Jacques DURANTEAU, MD,PhD, Principal Investigator, Affiliation: Assistance Publique - Hôpitaux de Paris

Overall contact:
Jacques DURANTEAU, MD,PhD, Phone: 01-45-21-39-36, Email: jacques.duranteau@bct.aphp.fr

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.

Official title: Personalized Haemodynamic Management of Septic Shock: Influence of Mean Arterial Pressure Level on Renal Function: Randomized Controlled Trial

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Acute kidney injury according to RIFLE score

Secondary outcome:

Need for renal replacement therapy

All cause mortality

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

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Any patient with septic shock in intensive care may be included in the next 6 to 16h

- Age > 18 years old

Exclusion Criteria:

- Chronic renal failure (Baseline serum creatinine > 120 mmol/L)

- Chronic cardiac failure (Left ventricle ejection fraction < 40%)

- Pregnancy

- Urinary Tract Infection

Jacques DURANTEAU, MD,PhD, Phone: 01-45-21-39-36, Email: jacques.duranteau@bct.aphp.fr

Reanimation Chirurgicale - Hôpital Kremlin Bicêtre, Kremlin Bicêtre 94275, France; Recruiting
Jacques DURANTEAU, MD,PhD, Phone: 01-45-21-39-36, Email: jacques.duranteau@bct.aphp.fr
Jacques DURANTEAU, MD, PhD, Principal Investigator

Starting date: January 2013
Last updated: June 13, 2014