Controlled Randomized Multi-centric Clinical Trial on the Effect of Citrulline on the Clinical and Biochemical Evolution of Patients With Sepsis.
Trial Snapshot
- Phase
- Phase 1
- Enrollment
- 160
- Locations
- 3
- Primary Endpoint
- Multiple organ failure
Study Overview
Brief Summary
Triple blind placebo-controlled study to determine if administering citrulline in patients with sepsis and severe sepsis slows progression to multiple organ failure and death, measuring biomarkers of endothelial dysfunction. Patients are divided into placebo or citrulline and followed up for 1 month.
Detailed Description
Consecutive patients with sepsis are being recited from intensive care unite of IMSS at the CMN Siglo XXI and CMN La Raza over the period of november 2015 through june 2016. After signing an informed consent they will be randomized into 80 for intervention arm and 80 for the placebo arm. All patients will receive usual medical treatment; and during seven days citurlline arm subjects will receive supplementation with oral or nasogastric citrulline (10 g/day), while other group patients will receive during seven days oral or nasogastric placebo (10 g/day) with no visible difference between these. Microalbuminuria and interleukines 1, 6, and 10 will be measured at randomization and at day 7. All subjects will be followed for 28 days, and after the follow-up period results will be analyzed to determine de efficacy and safety of citrulline, primary outcome are the incidence of multiple organic failure and death, also microalbuminuria levels 1,6,10-interleukines. We will use Student-t and Chi2 for statistical analysis.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Severe sepsis
- •Diagnosis of sepsis in the first 36 hours of hospitalization.
- •Informed Consent
- •Intestinal tract intact
Exclusion Criteria
- •Terminal cancer
- •Acute and chronic liver diseases
- •Chronic renal failure.
- •Acute renal failure AKIN III.
- •Pregnant and postpartum women
- •Dying patients.
- •Patients with cardiac arrest.
- •Active gastrointestinal bleeding.
- •Steroids or immunosuppressants.
- •Enrolled in another study intervention.
- •Citrulline allergy.
Outcomes
Primary Outcomes
Multiple organ failure
Time Frame: 1 month
Progression to multiple organ failure ending in death
Secondary Outcomes
No secondary outcomes reported
Investigators
Eduardo Almeida Gutiérrez
Head Researcher
Instituto Mexicano del Seguro Social