Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Emory University
With
Children's Healthcare of Atlanta
National Center for Complementary and Integrative Health (NCCIH)
The purpose of this study is to determine the effects of IV L-arginine hydrochloride therapy in children with sickle cell disease (SCD) and vaso-occlusive pain events (VOE). Specifically, the impact on total opioid use (mg/kg) over the duration of their emergency department (ED) visit and hospital stay will be evaluated.
Age
3–21
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
