Personalized Mean Arterial Pressure Management on Renal Function During Septic Shock

NCT01473498 | Terminated

• 1 other identifier: P091103
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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.

Conditions

Septic Shock; Acute Kidney Injury

Keywords

Sepsis; Acute kidney injury; Mean arterial pressure; Catecholamines; Renal doppler

Outcome Measures

Primary Outcomes (1)

• Acute kidney injury according to RIFLE score

  at 7 days

Secondary Outcomes (2)

• Need for renal replacement therapy

  during hospitalization

• All cause mortality

  at 28 days

Study Arms (2)

Test group

EXPERIMENTAL

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.

Other: Haemodynamic management

Control group

ACTIVE COMPARATOR

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.

Other: Haemodynamic management

Interventions

Haemodynamic management 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.

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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%)

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Reanimation Chirurgicale - Hôpital Kremlin Bicêtre

Le Kremlin-Bicêtre, France

Location

MeSH Terms

Conditions

Shock, Septic; Acute Kidney Injury; Sepsis

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Jacques DURANTEAU, MD,PhD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 14, 2011
• First Posted: November 17, 2011
• Study Start: January 1, 2013
• Primary Completion: September 1, 2015
• Study Completion: October 1, 2015
• Last Updated: April 13, 2026

Record last verified: 2020-01

Locations

FR (1)