Arginine Therapy for Sickle Cell Disease Pain

• Status: Completed
• Trial end date: 2021-02-21
• Target enrollment: 0
• Participant gender: All

Summary

The aim of this study is to determine whether giving extra arginine, a simple amino acid, to patients with sickle cell disease seeking treatment for a pain crisis (vaso-occlusive painful events (VOE) will decrease pain scores, decrease the need for pain medications or decrease length of hospital stay or emergency department visit. Funding Source - FDA OOPD.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Emory University
• Collaborators: Children's Healthcare of Atlanta; National Center for Complementary and Integrative Health (NCCIH)

Criteria

Inclusion Criteria:

• Established diagnosis of sickle cell disease (SCD); all genotypes

• Pain requiring medical care in an acute care setting (such as the emergency department or ED, hospital ward, day hospital, clinic) not attributable to non-sickle cell causes, that is moderate-to-severe requiring parenteral opioids

Exclusion Criteria:

• Decision to discharge home from the acute care setting

• Hemoglobin less than 5 gm/dL or immediate need for red cell transfusion anticipated within next 12 hours

• Hepatic dysfunction of SGPT greater than 3 times the upper value

• Renal dysfunction of creatinine greater than 1.0

• Mental status or neurological changes

• Acute stroke or clinical concern for stroke

• Pregnancy

• Allergy to arginine

• Two (2) or more ED visits for VOE within the last 7 days prior to CURRENT ED visit

• Hospitalization within 14 days

• Previous randomization in this arginine RCT (patient consented and screen failed before receiving study drug or placebo remains eligible for future participation).

• Use of inhaled nitric oxide, sildenafil or arginine within the last month

• PICU admission from the emergency department

• Hypotension requiring treatment with clinical intervention

• Acidosis with Co2≤ 16

• Newly started on HU for <3 months

• Not an appropriate candidate in the investigator's judgment

• Patient refusal