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Pilot Study of Fructose for Sickle Cell Crisis



Pilot Study of Fructose for Sickle Cell Crisis

For Condition: Sickle Cell Anemia
Status: Completed
Sponsor(s): National Center for Research Resources (NCRR) , Rehabilitation Institute of Chicago
Synopsis: 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.
Details: 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.
Eligibility:
Study Type:  Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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
Total Enrollment: 20

Location and Contact Information:

Overall Study Official:
DavidGreen,  Study Chair,  Rehabilitation Institute of Chicago


Additional Information:
Study ID Numbers:  199/11941;  NU-573
Study Start Date: August 1995
Record last reviewed: December 2001
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004797

Other Sickle Cell Anemia Studies:
1. Nitric Oxide to Improve Blood Flow in Sickle Cell Disease

2. A study of the efficacy and safety of ICA-17043 (with or without hydroxyurea) in patients with sickle cell anemia.

3. Bone Marrow Transplantation in Treating Children With Sickle Cell Disease

4. Decompression Coring Versus Conservative Therapy in Patients With Avascular Necrosis of the Hip Related to Sickle Cell Disease

5. Study of Allogeneic Bone Marrow Transplantation Using Matched, Related Donors in Patients With Nonmalignant Hematologic Disorders

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