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Acute Kidney Injury in Patients With Sickle Cell Disease

Acute Kidney Injury in Patients With Sickle Cell Disease

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03105271
Enrollment
60
Registered
2017-04-07
Start date
2017-01-01
Completion date
2022-01-31
Last updated
2022-02-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

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.

Interventions

None listed

Sponsors

Pfizer
CollaboratorINDUSTRY
National Heart, Lung, and Blood Institute (NHLBI)
CollaboratorNIH
University of Alabama at Birmingham
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
1 Years to 25 Years
Healthy volunteers
Yes

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

\-

Design outcomes

Primary

MeasureTime frameDescription
Incidence of Acute Kidney InjuryHospitalizations through study completion, an average of one yearEvaluate 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.One yearWe 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 AKItwo yearsWe will test the hypothesis that free heme and endothelin are elevated in patients that develop AKI as compared to patients without AKI.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026