Personalized Haemodynamic Management of Septic Shock: Influence of Mean Arterial Pressure Level on Renal Function: Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Enrollment
- 27
- Locations
- 2
- Primary Endpoint
- Acute kidney injury according to RIFLE score
Study Overview
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:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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%)
Arms & Interventions
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.
Intervention: Haemodynamic management (Other)
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: Haemodynamic management (Other)
Outcomes
Primary Outcomes
Acute kidney injury according to RIFLE score
Time Frame: at 7 days
Secondary Outcomes
- Need for renal replacement therapy(during hospitalization)
- All cause mortality(at 28 days)