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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 16 December 2017
Main ID:  NCT02430844
Date of registration: 27/04/2015
Prospective Registration: Yes
Primary sponsor: Sanjay Gandhi Postgraduate Institute of Medical Sciences
Public title: Role of Biomarkers in Predicting Contrast-induced Acute Kidney Injury in Critically Ill Patients
Scientific title: "Role of Biomarkers in Predicting Contrast-induced Acute Kidney Injury in Critically Ill Patients: a Prospective Observational Study"
Date of first enrolment: May 6, 2015
Target sample size: 85
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT02430844
Study type:  Observational
Study design:   
Phase:  N/A
Countries of recruitment
India
Contacts
Name:     Mohan Gurjar, MD
Address: 
Telephone:
Email:
Affiliation:  Sanjay Gandhi Postgraduate Institute of Medical Sciences (SGPGIMS)
Key inclusion & exclusion criteria

Inclusion Criteria:

- All ICU patients who are > 18 years and having normal renal function, requiring
radiographic contrast for diagnostic or interventional computed tomography procedure,
will be considered for inclusion.

Exclusion Criteria:

- Age <18 years

- Known Chronic Kidney Disease

- Patient already on dialysis

- Presence of Acute Kidney Injury (increase in SCr by 50% or decrease in GFR by 25%
within last 7 days)

- Recent exposure to radiographic contrast within 3 days of the study

- History of cardio/respiratory arrest during current illness

- Increase in serum creatinine levels of = 0.3 mg/dl from the baseline during the
previous 48 hours before contrast exposure.

- Known or suspected nephritic or nephrotic syndrome.

- A post-renal etiology of renal impairment

- Known allergy or hypersensitivity to radiographic contrast dye

- Pregnancy



Age minimum: 18 Years
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Acute Kidney Injury
Intervention(s)
Primary Outcome(s)
To analyse the role of plasma and urinary biomarkers (Neutrophil Gelatinase-Associated Lipocalin (NGAL), Cystatin C and Kidney Injury Molecule-1) in predicting contrast-induced acute kidney injury (CI-AKI) in critically ill patients. [Time Frame: 48 Hours after contrast exposure]
Secondary Outcome(s)
Secondary ID(s)
2015-34-IMP-83
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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