Pilot Study of Fructose for Sickle Cell Crisis

National Center for Research Resources (NCRR)

Status: Completed

Conditions: Sickle Cell Anemia

Treatments: Drug: placebo; Drug: fructose

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00004797

NU-573

199/11941

Details and patient eligibility

About

OBJECTIVES: I. Evaluate the efficacy and tolerability of fructose administered every 6 hours for up to 72 hours to patients in active sickle cell crisis.

II. Obtain tolerability information in selected patients treated with fructose for more than 72 hours.

Full description

PROTOCOL OUTLINE: In the first part of the study, patients are block-randomized (3:1) to a single intravenous dose of fructose or placebo. The dose of fructose is escalated in each successive group after tolerability data are evaluated.

In the second part of the study, patients are randomly assigned (1:1) to fructose or placebo administered intravenously every 6 hours for 72 hours. The dose of fructose is the highest well-tolerated dose determined in Study 1 or the most tolerated dose for the patient. Patients who just completed Study 1 may participate if they are clearly in a separate crisis and continue to meet entry criteria.

Patients whose symptoms persist for more than 72 hours after fructose or placebo are eligible to receive additional fructose every 6 hours until symptoms subside.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics-- Sickle cell crisis requiring hospital admission Crisis began at least 12 hours prior to admission Medical records documenting sickle cell disease and previous crisis requiring hospital visit during the last 24 months available at study site No thalassemia No complex hemoglobinopathy involving thalassemia and sickle cell disease

--Patient Characteristics-- Renal: Creatine no greater than 2.2 mg/dL No requirement for regular dialysis Other: Weight above or below 30% of ideal body weight No fructose intolerance No insulin-dependent diabetes No HIV seropositivity No acquired immune deficiency syndrome (AIDS) or AIDS-related illness No general anesthetic for 7 days prior to and 2 days following entry Primary language allows communication with study staff Demonstration of ability to read and understand pain scales required Ability to identify crisis starting time accurately, i.e., to within 6 hours