Personalized Mean Arterial Pressure Management on Renal Function During Septic Shock (DORESEP)

This study is currently recruiting participants.
Verified September 2013 by Assistance Publique - Hôpitaux de Paris
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01473498
First received: October 14, 2011
Last updated: September 12, 2013
Last verified: September 2013

October 14, 2011
September 12, 2013
January 2013
November 2013   (final data collection date for primary outcome measure)
Acute kidney injury according to RIFLE score [ Time Frame: at 7 days ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01473498 on ClinicalTrials.gov Archive Site
  • Need for renal replacement therapy [ Time Frame: during hospitalization ] [ Designated as safety issue: Yes ]
    including metabolic indications (Azotemia Serum urea ≥ 36mmol/L (100 mg/dL) ; Uremic complications : encephalopathy, pericarditis, bleeding ; Hyperkalemia K+ ≥ 6 mmol/L and/or electrocardiogram abnormalities ; Hypermagnesemia ≥4 mmol/L and/or anuria/absent deep tendon reflexes ; Acidosis Serum pH ≤ 7.15), Oligo-anuria Urine output <200mL/12 h or anuria, Fluid overload like Diuretic-resistant organ edema in the presence of acute kidney injury.
  • All cause mortality [ Time Frame: at 28 days ] [ Designated as safety issue: Yes ]
    All Cause mortality at 28 days, including refractory shock, refractory hypoxia, multiple organ failure, decisions to forgo life-sustaining therapies (DFLSTs)
Same as current
Not Provided
Not Provided
 
Personalized Mean Arterial Pressure Management on Renal Function During Septic Shock
Personalized Haemodynamic Management of Septic Shock: Influence of Mean Arterial Pressure Level on Renal Function: Randomized Controlled Trial

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.

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
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Septic Shock
  • Acute Kidney Injury
  • 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 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.

  • 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.

  • Experimental: 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. Key details, e.g., for drugs include dosage form, dosage, frequency and duration.

    Intervention: Other: Haemodynamic management
  • Active Comparator: 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.

    Intervention: Other: Haemodynamic management
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
60
December 2013
November 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Jacques DURANTEAU, MD,PhD 01-45-21-39-36 jacques.duranteau@bct.aphp.fr
Contact: Adrien BOUGLE, MD 06-64-82-56-29 adrien.bougle@gmail.com
France
 
NCT01473498
P091103
No
Assistance Publique - Hôpitaux de Paris
Assistance Publique - Hôpitaux de Paris
Not Provided
Principal Investigator: Jacques DURANTEAU, MD,PhD Assistance Publique - Hôpitaux de Paris
Assistance Publique - Hôpitaux de Paris
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP