Effect of Citrulline on the Clinical and Biochemical Evolution of Patients With Sepsis. (CITRUSEP)

Instituto Mexicano del Seguro Social

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Sepsis

Treatments: Dietary Supplement: Citrulline malate

Study type: Interventional

Funder types: Other

Identifiers

NCT02370030

R-2014-785-082

Details and patient eligibility

About

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.

Full 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.

Enrollment: 160 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Sepsis
• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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160 participants in 2 patient groups, including a placebo group

Intervention

Active Comparator group

Description:

Oral or nasogastric administration of 10 g citrulline malate daily. Blood and urine samples to determine biomarkers of endothelial damage (IL 6, IL 10 , nitric oxide and microalbuminuria), with a second sampling after 7 days of intervention. Disease severity will be measure with various scales, including APACHE II, SOFA

Treatment:

Dietary Supplement: Citrulline malate

Placebo

Placebo Comparator group

Description:

10 g of maltodextrin will be substituted for the citrulline. Blood and urine samples to determine biomarkers of endothelial damage (IL 6, IL 10 , nitric oxide and microalbuminuria), with a second sampling after 7 days of intervention. Disease severity will be measure with various scales, including APACHE II, SOFA

Treatment:

Dietary Supplement: Citrulline malate