RECRUITING

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

Conditions

Sickle Cell Disease Vaso-occlusive Pain Episode sickle cell pain crisis citrulline

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The goal of this clinical trial is to learn if intravenous citrulline works to treat acute pain in hospitalized patients with sickle cell disease. It will also learn about the safety of intravenous citrulline. The main questions it aims to answer are: * Does intravenous citrulline decrease the duration of sickle cell pain during hospitalization * What medical problems do participants have when taking intravenous citrulline? Researchers will compare intravenous citrulline to a placebo (a look-alike substance that contains no drug) to see if intravenous citrulline works to treat acute pain. Participants will: * Receive baseline tests and intravenous citrulline for 16 hours during the hospital stay * After hospital discharge, visit the clinic in about 30 days for checkup and tests

Official Title

A Phase 2 Randomized Double-blind, Placebo-controlled Clinical Trial of Intravenous Citrulline for Vaso-occlusive Pain Episode in Hospitalized Patients with Sickle Cell Disease (CONQUER SCD Pain Trial)

Quick Facts

Study Start:2024-11

Study Completion:2029-03

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06635902

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:4 Years to 21 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD, ADULT

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Contacts and Locations

Study Contact

Jillian Baker, RN

CONTACT

202-476-1311

jbaker5@childrensnational.org

Principal Investigator

Suvankar Majumdar, MD

PRINCIPAL_INVESTIGATOR

Children's National Research Institute

Study Locations (Sites)

Children's National Hospital

Washington, District of Columbia, 20010

United States

Collaborators and Investigators

Sponsor: Suvankar Majumdar

Suvankar Majumdar, MD, PRINCIPAL_INVESTIGATOR, Children's National Research Institute

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-11

Study Completion Date2029-03

Study Record Updates

Study Start Date2024-11

Study Completion Date2029-03

Terms related to this study

Keywords Provided by Researchers

sickle cell disease
sickle cell pain crisis
citrulline

Additional Relevant MeSH Terms

Sickle Cell Disease
Vaso-occlusive Pain Episode