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Acute Kidney Injury in Patients With Sickle Cell Disease

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ClinicalTrials.gov Identifier: NCT03105271
Recruitment Status : Recruiting
First Posted : April 7, 2017
Last Update Posted : October 25, 2018
Sponsor:
Collaborators:
Pfizer
National Insitutes of Health, NHLBI
Information provided by (Responsible Party):
Jeffrey D. Lebensburger, DO, University of Alabama at Birmingham

Tracking Information
First Submitted Date March 23, 2017
First Posted Date April 7, 2017
Last Update Posted Date October 25, 2018
Actual Study Start Date January 1, 2017
Estimated Primary Completion Date January 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 13, 2017)
  • 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.
Original Primary Outcome Measures
 (submitted: April 3, 2017)
  • 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, as determined by cystatin C, obtained during non-acute clinic visit both immediately prior to their AKI events and after AKI events.
Change History Complete list of historical versions of study NCT03105271 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Acute Kidney Injury in Patients With Sickle Cell Disease
Official Title Acute Kidney Injury in Patients With 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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
Urine and blood will be stored in biorepository.
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.
Condition
  • Sickle Cell Disease
  • Kidney Injury
  • Kidney Diseases
  • Kidney Disease, Chronic
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: April 3, 2017)
60
Original Estimated Enrollment Same as current
Estimated Study Completion Date January 2020
Estimated Primary Completion Date January 2020   (Final data collection date for primary outcome measure)
Eligibility 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:

-

Sex/Gender
Sexes Eligible for Study: All
Ages 1 Year to 25 Years   (Child, Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Jeffrey D Lebensburger, DO MSPH 205 638-9285 jlebensburger@peds.uab.edu
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03105271
Other Study ID Numbers AKISCD
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Jeffrey D. Lebensburger, DO, University of Alabama at Birmingham
Study Sponsor University of Alabama at Birmingham
Collaborators
  • Pfizer
  • National Insitutes of Health, NHLBI
Investigators Not Provided
PRS Account University of Alabama at Birmingham
Verification Date October 2018