Acute Kidney Injury in Patients With Sickle Cell Disease
NCT03105271
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Adult Trials: 18+ Years
- Patients with HbSS or SB0 thalassemia admitted for vaso-occlusive pain crisis or acute chest syndrome
- Able to sign informed consent
-
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- Birmingham, Alabama
| Descriptive Information | |||||
|---|---|---|---|---|---|
| Brief Title | Acute Kidney Injury in Patients With Sickle Cell Disease | ||||
| Official Title | Acute Kidney Injury in Patients With Sickle Cell Disease | ||||
| Brief Summary | Patients with sickle cell disease may be at risk for acute kidney injury (AKI)during sickle cell crisis (pain or acute chest syndrome). This study will evaluate the role of hemolysis during SCD crisis on the development of AKI and the role for monitoring urine biomarkers during an admission for crisis and during well clinic follow-up. | ||||
| Detailed Description | Patients admitted to the hospital for acute chest syndrome or vaso-occlusive pain events may consent to participate in this study. Patients will consent to daily blood and urine collection during their hospitalization and during well clinic visits. Each AM, participants will have blood and urine collected, processed, and strored for future analysis of hemolytic markers and biomarkers of kidney injury. Patients will also have strict urine output recorded. Acute kidney injury (AKI) will be defined by the current KDIGO definition based on either a rise in serum creatinine or decline in urine output. Patient medical course will be reviewed to determine interventions and outcomes of their admission based on the development of AKI. | ||||
| Study Type | Observational | ||||
| Study Design | Observational Model: Cohort Time Perspective: Prospective | ||||
| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Retention: Samples Without DNA Description: Urine and blood will be stored in biorepository. | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | Patients with HbSS or SB0 thalassemia admitted to Children's of Alabama for a vaso-occlusive pain crisis or acute chest syndrome. | ||||
| Condition |
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| Intervention | Not Provided | ||||
| Study Groups/Cohorts | Not Provided | ||||
| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||
| Recruitment Information | |||||
| Recruitment Status | Recruiting | ||||
| Estimated Enrollment | 60 | ||||
| Original Estimated Enrollment | Same as current | ||||
| Estimated Study Completion Date | January 2022 | ||||
| Estimated Primary Completion Date | January 2022 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria: - | ||||
| Sex/Gender |
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| Ages | 1 Year to 25 Years (Child, Adult) | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts |
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| Listed Location Countries | United States | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number | NCT03105271 | ||||
| Other Study ID Numbers | AKISCD | ||||
| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement |
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| Responsible Party | Jeffrey D. Lebensburger, DO, University of Alabama at Birmingham | ||||
| Study Sponsor | University of Alabama at Birmingham | ||||
| Collaborators |
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| Investigators | Not Provided | ||||
| PRS Account | University of Alabama at Birmingham | ||||
| Verification Date | March 2020 | ||||