Acute Kidney Injury in Patients With Sickle Cell Disease
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03105271|
Recruitment Status : Recruiting
First Posted : April 7, 2017
Last Update Posted : March 12, 2020
|Condition or disease|
|Sickle Cell Disease Kidney Injury Kidney Diseases Kidney Disease, Chronic|
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|
|Estimated Enrollment :||60 participants|
|Official Title:||Acute Kidney Injury in Patients With Sickle Cell Disease|
|Actual Study Start Date :||January 1, 2017|
|Estimated Primary Completion Date :||January 2022|
|Estimated Study Completion Date :||January 2022|
- Incidence of Acute Kidney Injury [ Time Frame: Hospitalizations through study completion, an average of one year ]Evaluate the incidence of KDIGO defined AKI among patients admitted for pain or acute chest syndrome. AKI is defined by KDIGO as an increase in SCr by 50% or ≥0.3mg/dL from baseline, or UOP <0.5mL/kg/hr for 12 hrs
- Impact of Acute Kidney Injury during Pain or Acute Chest Syndrome Hospitalizations on the Development of Chronic Kidney Disease as defined by KDIGO. [ Time Frame: One year ]We will evaluate the impact of AKI on eGFR. To evaluate this impact, we will compare the change in eGFR, as measured by cystatin C, obtained from each patient during their non-acute clinic visit both immediately prior to their AKI events and after AKI events.
- Impact of free heme and endothelin on development of AKI [ Time Frame: two years ]We will test the hypothesis that free heme and endothelin are elevated in patients that develop AKI as compared to patients without AKI.
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03105271
|Contact: Jeffrey D Lebensburger, DO MSPH||205 email@example.com|
|United States, Alabama|
|University of Alabama at Birmingham||Recruiting|
|Birmingham, Alabama, United States, 35223|
|Contact: Jeffrey D Lebensburger, DO firstname.lastname@example.org|