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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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03105271
Recruitment Status : Completed
First Posted : April 7, 2017
Last Update Posted : February 7, 2022
Sponsor:
Collaborators:
Pfizer
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Jeffrey D. Lebensburger, DO, University of Alabama at Birmingham

Study Description
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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.

Condition or disease
Sickle Cell Disease Kidney Injury Kidney Diseases Kidney Disease, Chronic

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 Design
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Study Type : Observational
Actual Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Acute Kidney Injury in Patients With Sickle Cell Disease
Actual Study Start Date : January 1, 2017
Actual Primary Completion Date : January 31, 2022
Actual Study Completion Date : January 31, 2022

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. 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

  2. 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.

  3. 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
Urine and blood will be stored in biorepository.

Eligibility Criteria
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Ages Eligible for Study:   1 Year to 25 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Criteria

Inclusion Criteria:

  • Patients with HbSS or SB0 thalassemia admitted for vaso-occlusive pain crisis or acute chest syndrome
  • Able to sign informed consent

Exclusion Criteria:

-

Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35223
Sponsors and Collaborators
University of Alabama at Birmingham
Pfizer
National Heart, Lung, and Blood Institute (NHLBI)
More Information
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Publications:

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Responsible Party: Jeffrey D. Lebensburger, DO, Principal Investigator, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT03105271    
Other Study ID Numbers: AKISCD
First Posted: April 7, 2017    Key Record Dates
Last Update Posted: February 7, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Kidney Diseases
Acute Kidney Injury
Renal Insufficiency, Chronic
Anemia, Sickle Cell
Wounds and Injuries
Urologic Diseases
Renal Insufficiency
 Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn