Personalized Mean Arterial Pressure Management on Renal Function During Septic Shock

NCT ID: NCT01473498

Last Updated: 2020-01-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-01-31
• Study Completion Date: 2015-11-30

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

Conditions

Septic Shock; Acute Kidney Injury

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Test group

Patients will be treated with fluid and norepinephrine to achieve and maintain a mean arterial pressure of 65 mm Hg. Then they will be randomized in two groups.

In the first group (study group, n=30), mean arterial pressure will be increased to 85 mm Hg for 72 hours by increasing the dose of norepinephrine in patients (A maximum dose of 1.2 mcg / kg / min is not exceeded). Key details, e.g., for drugs include dosage form, dosage, frequency and duration.

Group Type: EXPERIMENTAL

Haemodynamic management

Intervention Type: OTHER

Patients will be treated with fluid and norepinephrine to achieve and maintain a mean arterial pressure of 65 mm Hg. Then they will be randomized in two groups.

In this group (control group, n=30), mean arterial pressure will be maintained at 65 mm Hg.

Control group

Patients will be treated with fluid and norepinephrine to achieve and maintain a mean arterial pressure of 65 mm Hg. Then they will be randomized in two groups.

In this group (control group, n=30), mean arterial pressure will be maintained at 65 mm Hg.

Group Type: ACTIVE_COMPARATOR

Haemodynamic management

Intervention Type: OTHER

Patients will be treated with fluid and norepinephrine to achieve and maintain a mean arterial pressure of 65 mm Hg. Then they will be randomized in two groups.

In the first group (study group, n=30), mean arterial pressure will be increased to 85 mm Hg for 72 hours by increasing the dose of norepinephrine in patients.

Interventions

Haemodynamic management

Patients will be treated with fluid and norepinephrine to achieve and maintain a mean arterial pressure of 65 mm Hg. Then they will be randomized in two groups.

In the first group (study group, n=30), mean arterial pressure will be increased to 85 mm Hg for 72 hours by increasing the dose of norepinephrine in patients.

Intervention Type: OTHER

Haemodynamic management

Patients will be treated with fluid and norepinephrine to achieve and maintain a mean arterial pressure of 65 mm Hg. Then they will be randomized in two groups.

In this group (control group, n=30), mean arterial pressure will be maintained at 65 mm Hg.

Intervention Type: OTHER

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%)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jacques DURANTEAU, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

Reanimation Chirurgicale - Hôpital Kremlin Bicêtre

Le Kremlin-Bicêtre, , France

Countries

France

Other Identifiers

P091103

Identifier Type: -

Identifier Source: org_study_id