What this study is
The purpose of this study is to determine whether giving extra arginine to patients with sickle cell disease seeking treatment for vaso-occlusive painful events (VOE) will decrease pain scores, decrease need for pain medications or decrease length of hospital stay or emergency department visit.
What's being tested
- Arginine
Intervention · DRUG
Arginine will be dispensed intravenously (in the vein) in the standard dose of arginine as 100 mg/kg three times a day for seven days or until discharge. * Loading dose: 200 mg/kg once * Continuous IV: 300 mg/kg/24 hours
- Arginine (Loading)
Intervention · DRUG
Arginine will be dispensed intravenously (in the vein) as an initial bolus (loading) at each specified group dose once, followed by a standard dose of 100mg/kg every 8 hours until discharge or for a total of 21 doses of arginine, whichever comes first.
- Arginine (Continuous)
Intervention · DRUG
Arginine will be dispensed intravenously (in the vein) as a continuous IV infusion of 300 mg/kg/24hr
Study details
- Official title
- Arginine Therapy for the Treatment of Vaso-Occlusive Events in Children With Severe Sickle Cell Disease
- Sponsor
- Emory University
- Conditions
- Sickle Cell Disease
- Enrolling
- 21 people
- Starts
- 2015-05
- Est. completion
- 2026-07
- Design
- Open-label, randomized, crossover, Phase 1, Phase 2
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 7 Years – 21 YearsSex ALLHealthy volunteers Not acceptedYou may qualify if
- Established diagnosis of sickle cell disease--Hemoglobin SS (Hb-SS) or Sβᴼ-thalassemia
- 7-21 years of age
- Weight >= 25kg (55lbs)
- Pain requiring medical care in an acute care setting (emergency department (ED), hospital ward, day hospital, clinic) requiring parenteral opioids, not attributable to non-sickle cell causes.
You can't join if
- Decision to discharge home from acute care setting.
- Diagnosis of sickle cell disease with any of the following types: hemoglobin SC disease (HbSC), hemoglobin beta thalassemia (Hb-Beta Thal), hemoglobin SD disease (HbSD), hemoglobin SE disease (HbSE), hemoglobin SO disease (HbSO), hemoglobin AS carrier (Hb AS)
- Hemoglobin less than 5 gm/dL
- Immediate Red cell transfusion anticipated
- Renal dysfunction: Creatinine >1.0 or 2 x baseline
- Mental status or neurological changes
- Acute stroke or clinical concern for stroke
- Pregnancy
- Allergy to arginine
- Previous hospitalization < 7 days
- Use of inhaled nitric oxide, sildenafil or arginine within the last 14 days
- Not an appropriate candidate in the investigator's judgement
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
Loading treatment details…
Study locations (2)
2 openContact for every open site
- Arnetria Dancy · Contact404-778-1873arnetria.dancy@emory.edu
Children's Healthcare fo Atlanta at Hughes Spalding
Atlanta, Georgia, United States
RecruitingChildren's Healthcare of Atlanta at Arthur M. Blank Hospital
Atlanta, Georgia, United States
Recruiting
Study team
Sponsor
Emory University
Study ID IRB00077736
Principal investigator
Claudia Morris, MD
Emory University
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.