Intravenous L-Citrulline for Vaso-occlusive Pain Episode in Sickle Cell Disease

Launched by SUVANKAR MAJUMDAR · Oct 9, 2024

Keywords

ClinConnect Summary

This clinical trial is studying whether intravenous (IV) L-citrulline can help reduce painful episodes in patients with sickle cell disease who are hospitalized. Sickle cell disease can cause severe pain crises, known as vaso-occlusive pain episodes, and this trial aims to see if L-citrulline can lessen the pain and how safe it is to use. Participants in the trial will receive either L-citrulline or a placebo (a substance that looks like the drug but has no active ingredients) over a 16-hour period while they are in the hospital. The trial will also check on any medical issues that may arise during treatment, and participants will have a follow-up visit about 30 days after they leave the hospital.

To be eligible for this trial, participants should be between the ages of 4 and 21 and have sickle cell disease with a current painful episode that requires hospital care and strong pain medications. However, those with certain conditions, like severe pain lasting more than 3 days or multiple recent hospitalizations, will not be able to join. This study is currently recruiting participants and aims to better understand how L-citrulline might help manage pain in sickle cell disease.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Sickle cell disease (all genotypes)
• • Patients with sickle cell disease ages 4 to 21 years old
• • Presence of sickle cell vaso-occlusive pain episode requiring hospitalization and parenteral opioid therapy
• • Able to randomize to study drug/placebo within 12 hours of first dose of parenteral opioid in the Emergency Department
• Exclusion Criteria:
• • Current pain lasting \>3 days.
• • \>9 hospitalizations in the prior year
• • Presence of any other complication related to sickle cell disease requiring the hospitalization such as splenic sequestration, hepatic sequestration, stroke, transient ischemic attack, etc.
• • History of opioid use disorder, chronic pain or medical regimen requiring daily opioid use.
• • Severe anemia (hemoglobin \<6g/dL)
• • Pregnant (as confirmed by a positive urine pregnancy test) or lactating female.
• • Alanine/aspartate transferase \>2x upper limit of normal laboratory range for age.
• * Subject has the following serum creatinine:
• • Age 4 to 13 years \> 0.9 mg/dL
• • Age 14 to 17 years 1.0 mg/dL
• • Age ≥18 years \>1.5mg/dL
• • Presence of acute chest syndrome, sepsis, bacterial infection, hemodynamic instability
• • Use of L-glutamine
• • History of allergic reaction to L-citrulline products