Acute Kidney Injury in Patients With Sickle Cell Disease

Sickle Cell Disease Clinical Trial

Official title:

Acute Kidney Injury in Patients With Sickle Cell Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03105271
• Other study ID #: AKISCD
• Status: Completed
• Start date: January 1, 2017
• Est. completion date: January 31, 2022

Study information

• Verified date: February 2022
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: January 31, 2022
• Est. primary completion date: January 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Year to 25 Years

Eligibility

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:

-

Related Conditions & MeSH terms

• Acute Kidney Injury
• Anemia, Sickle Cell
• Kidney Disease, Chronic
• Kidney Diseases
• Kidney Injury
• Renal Insufficiency, Chronic
• Sickle Cell Disease
• Wounds and Injuries

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama

Sponsors (3)

Lead Sponsor	Collaborator
University of Alabama at Birmingham	National Heart, Lung, and Blood Institute (NHLBI), Pfizer

Country where clinical trial is conducted

United States, 

References & Publications (3)

Baddam S, Aban I, Hilliard L, Howard T, Askenazi D, Lebensburger JD. Acute kidney injury during a pediatric sickle cell vaso-occlusive pain crisis. Pediatr Nephrol. 2017 Aug;32(8):1451-1456. doi: 10.1007/s00467-017-3623-6. Epub 2017 Feb 25. — View Citation

Lebensburger JD, Palabindela P, Howard TH, Feig DI, Aban I, Askenazi DJ. Prevalence of acute kidney injury during pediatric admissions for acute chest syndrome. Pediatr Nephrol. 2016 Aug;31(8):1363-8. doi: 10.1007/s00467-016-3370-0. Epub 2016 Mar 24. — View Citation

Oakley J, Zahr R, Aban I, Kulkarni V, Patel RP, Hurwitz J, Askenazi D, Hankins J, Lebensburger J. Acute Kidney Injury during Parvovirus B19-Induced Transient Aplastic Crisis in Sickle Cell Disease. Am J Hematol. 2018 May 14. doi: 10.1002/ajh.25140. [Epub ahead of print] — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Acute Kidney Injury	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	Hospitalizations through study completion, an average of one year
Primary	Impact of Acute Kidney Injury during Pain or Acute Chest Syndrome Hospitalizations on the Development of Chronic Kidney Disease as defined by KDIGO.	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.	One year
Primary	Impact of free heme and endothelin on development of AKI	We will test the hypothesis that free heme and endothelin are elevated in patients that develop AKI as compared to patients without AKI.	two years