Acute Kidney Injury in Patients With Sickle Cell Disease

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.

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Key information

Conditions

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

Age range

1 year–25 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Alabama at Birmingham

Birmingham, Alabama, 35223, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)
Pfizer

Registry information

Important dates

Study start: 2017
Primary completion: 2022
Study completion: 2022
First posted: Apr 7, 2017
Registry last updated: Feb 7, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed