Evaluating blood pressure effects on kidney function in septic shock
Relation Between Mean Arterial Pressure and Renal Resistive Index in the Early Phase of Septic Shock
This study is testing if raising blood pressure in patients with septic shock can help improve their kidney function.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Angers Government |
| Locations | 1 site (Angers) |
| Trial ID | NCT04281277 on ClinicalTrials.gov |
What this trial studies
This study investigates the relationship between mean arterial pressure (MAP) and renal resistive index in patients experiencing septic shock. It aims to determine if an increase in MAP from 65 mmHg to 85 mmHg can predict improved renal function, as measured by changes in renal resistive index. Patients will be monitored after stabilization at both MAP levels, and their renal function will be assessed on the seventh day. The trial will involve randomizing patients into two groups based on their response to the renal resistive index.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older admitted to the intensive care unit with arterial hypotension due to proven or suspected sepsis.
Not a fit: Patients with pre-existing chronic renal failure or those requiring immediate renal replacement therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management strategies for kidney function in patients with septic shock.
How similar studies have performed: While the specific approach of this study is novel, previous studies have indicated a correlation between MAP and renal function in septic patients.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * adult patients (≥ 18 ans) * Admitted to the intensive care unit of Angers with * arterial hypotension requiring the etablishment of catecholamines * In a context of proven or suspected sepsis, whaterver the cause of this infection. * norepinephrine dose ⩾ 0.1µg/kg/min * After 2 hours of stabilization at 65 mmHg of mean arterial pressure Exclusion Criteria: * Pre-existing chronic renal failure (glomerular filtration rate \< 60 mL/min with MDRD) * Solitary kidney (anatomical or functional) * History of united or bilateral stenosis of the renal arteries * decision to stop or limit treatment * patient with an emergency indication of renal replacement therapy (severe hyperkalemia, severe metabolical acidosis with pH \<7.15, acute pulmonary edema due to fluid overload resulting in severe hypoxemia, serum urea concentration \> 40 mmol/l and oliguria/anuria \> 72 h.) * pregnant, lactating or parturient woman * patient deprived of liberty by judicial or administrative decision * patient with psychiatric compulsory care * patient subject to legal protection measures
Where this trial is running
Angers
- CHU Angers. Médecine Intensive Réanimation et médecine hyperbare — Angers, France (Recruiting)
Study contacts
- Principal investigator: Pierre ASFAR, MD PHD — University Hospital, Angers
- Study coordinator: Nicolas FAGE, Resident
- Email: fage.nicolas@gmail.com
- Phone: 0241355865
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.