Acute Kidney Injury in Patients With Sickle Cell Disease

NCT03105271 | Completed

• 1 other identifier: AKISCD
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Sickle Cell Disease; Kidney Injury; Kidney Diseases; Kidney Disease, Chronic

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Eligibility Criteria

• Age: 1 Year - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• Pfizer: collaborator
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35223, United States

Location

Related 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.

  PMID: 28238158 BACKGROUND

• 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.

  PMID: 27011218 BACKGROUND

• 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 14:10.1002/ajh.25140. doi: 10.1002/ajh.25140. Online ahead of print. No abstract available.

  PMID: 29756409 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Urine and blood will be stored in biorepository.

MeSH Terms

Conditions

Anemia, Sickle Cell; Kidney Diseases; Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Renal Insufficiency; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 23, 2017
• First Posted: April 7, 2017
• Study Start: January 1, 2017
• Primary Completion: January 31, 2022
• Study Completion: January 31, 2022
• Last Updated: February 7, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)