The effect of L-citrulline supplementation in ventilated intensive care unit patients

The effect of L-citrulline supplementation in ventilated intensive care unit patients: A double-blind randomized controlled trial

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20210920052530N1

Enrollment

Registered

2022-06-21

Start date

2022-01-20

Completion date

Unknown

Last updated

2022-06-27

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

Conditions

Ventilated intensive care unit patients. Complication of respirator [ventilator]

Interventions

Intervention 1: Intervention group: Patients in the citrulline group will receive 10 grams of L-citrulline powder daily for 7 days. Intervention 2: Control group: Patients in the placebo group will re

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Required invasive ventilation via an intubation or tracheotomy tube for at least 72 hours after study entry Expected to survive and remain in the ICU for at least 96 hours after its onset

Exclusion criteria

Exclusion criteria: The age of fewer than 18 years Pregnancy Previous allergy to citrulline or arginine A history of gastrointestinal disease, digestive tract surgery, intestinal obstruction, paralytic ileus, intestinal ischemia, septic patients, and hyperthyroidism

Design outcomes

Primary

Measure	Time frame
Ventilator dependence. Timepoint: Count the number of ventilator dependence days up to 28 days after supplementation. Method of measurement: Count the number of ventilator dependence days.;Mortality Rate. Timepoint: Number of deaths due to a specific disease divided by the total number of patients up to 28 days after supplementation. Method of measurement: Number of deaths due to a specific disease divided by the total number of patients.;Evaluate the severity of the disease. Timepoint: Before the intervention and on days 7 and 28 after starting the supplement. Method of measurement: Measurement of disease severity is calculated based on the parameters of blood pressure, blood gases and patient's consciousness.;Evaluate the malfunction of multi-organ. Timepoint: Before the intervention and on days 7 and 28 after starting the supplement. Method of measurement: The Multi-Organ Dysfunction Questionnaire is calculated based on markers such as blood pressure, respiratory gases, respiratory support, bilirubin, platelets and creatinine, and the patient's urea.;Clinical Pulmonary Infection Score (CPIS). Timepoint: Before the intervention and on days 7 and 28 after starting the supplement. Method of measurement: Using the CPIS questionnaire.;Duration of hospitalization. Timepoint: The interval between the period of admission and the period of discharge from the hospital in terms of days. Method of measurement: The interval between the period of admission and the period of discharge from the hospital in terms of days.	—

Measure

Time frame

Ventilator dependence. Timepoint: Count the number of ventilator dependence days up to 28 days after supplementation. Method of measurement: Count the number of ventilator dependence days.;Mortality Rate. Timepoint: Number of deaths due to a specific disease divided by the total number of patients up to 28 days after supplementation. Method of measurement: Number of deaths due to a specific disease divided by the total number of patients.;Evaluate the severity of the disease. Timepoint: Before the intervention and on days 7 and 28 after starting the supplement. Method of measurement: Measurement of disease severity is calculated based on the parameters of blood pressure, blood gases and patient's consciousness.;Evaluate the malfunction of multi-organ. Timepoint: Before the intervention and on days 7 and 28 after starting the supplement. Method of measurement: The Multi-Organ Dysfunction Questionnaire is calculated based on markers such as blood pressure, respiratory gases, respiratory support, bilirubin, platelets and creatinine, and the patient's urea.;Clinical Pulmonary Infection Score (CPIS). Timepoint: Before the intervention and on days 7 and 28 after starting the supplement. Method of measurement: Using the CPIS questionnaire.;Duration of hospitalization. Timepoint: The interval between the period of admission and the period of discharge from the hospital in terms of days. Method of measurement: The interval between the period of admission and the period of discharge from the hospital in terms of days.

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Secondary

Measure	Time frame
Blood indicators. Timepoint: Before the intervention and 7 days after starting the supplement. Method of measurement: CRP is measured by the method of agglutination of latex particles on the slide (ENISON Co kits). Albumin is assessed with a commercially available enzyme-linked immunosorbent assay (ELISA) kit (Abcam). Blood urea nitrogen (BUN) is determined using enzymatic methods. Alanine transaminase (ALT), aspartate transaminase (AST), and lactate dehydrogenase (LDH) are measured based on the method recommended by the IFCC (International Federation of Clinical Chemistry).	—

Measure

Time frame

Blood indicators. Timepoint: Before the intervention and 7 days after starting the supplement. Method of measurement: CRP is measured by the method of agglutination of latex particles on the slide (ENISON Co kits). Albumin is assessed with a commercially available enzyme-linked immunosorbent assay (ELISA) kit (Abcam). Blood urea nitrogen (BUN) is determined using enzymatic methods. Alanine transaminase (ALT), aspartate transaminase (AST), and lactate dehydrogenase (LDH) are measured based on the method recommended by the IFCC (International Federation of Clinical Chemistry).

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactMohammad Reza Asgary

Artesh University of Medical Sciences

mohammadreza.askary1994@gmail.com+98 21 4382 2449

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026