Skip to content

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

Controlled Randomized Multi-centric Clinical Trial on the Effect of Citrulline on the Clinical and Biochemical Evolution of Patients With Sepsis.

Status
UNKNOWN
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02370030
Acronym
CITRUSEP
Enrollment
160
Registered
2015-02-24
Start date
2014-11-30
Completion date
2016-12-31
Last updated
2015-08-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sepsis

Keywords

sepsis, citrulline, endothelial, toxemia, endothelial determination of progression, with vs without citrulline

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.

Interventions

DIETARY_SUPPLEMENTCitrulline malate

Active comparator: 10 g/day citrulline malate during 7 days

Sponsors

Instituto Mexicano del Seguro Social
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Multiple organ failure1 monthProgression to multiple organ failure ending in death

Countries

Mexico

Contacts

Primary ContactEduardo Almeida Gutierrez, MSc
almeida_90210@yahoo.com.mx+52-55-5627-6900

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026