- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00004797
Pilot Study of Fructose for Sickle Cell Crisis
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Enrollment
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
Collaborators and Investigators
Collaborators
Investigators
- Study Chair: David Green, Shirley Ryan AbilityLab
Study record dates
Study Major Dates
Study Start
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 199/11941
- NU-573
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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