Role of Biomarkers in Predicting Contrast-induced Acute Kidney Injury in Critically Ill Patients

NCT02430844 | Completed

• 1 other identifier: 2015-34-IMP-83
• Study Type: observational
• Target: 85
• Locations: 1 country
• Sites: 1

Brief Summary

Title: "Role of biomarkers in predicting contrast-induced acute kidney injury in critically ill patients: a prospective observational study" Objective: 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. Summary of the project: Acute deterioration of renal function after intravenous administration of radiocontrast media, i.e. increase in serum creatinine concentration of more than 0.5 mg/dl or 25% above baseline within 48 hours, is referred to as contrast-induced kidney injury (CI-AKI). The increasing number of diagnostic procedures requiring radiographic contrast has parallel increase in the incidence of CI-AKI. CI-AKI is described as the third most common cause of new AKI in hospitalized patients. Occurrence of CI-AKI is reported up to 55% in high risk patients like presence pre-existing chronic renal dysfunction, diabetes, hypertension, chronic heart failure, advanced age, volume depletion, uses of concurrent nephrotoxic medication. These risk factors for CI-AKI are common in critically ill patients. Recently, different urinary and serum proteins have been intensively investigated as possible biomarkers for the early diagnosis of AKI, which includes Neutrophil Gelatinase-Associated Lipocalin (NGAL), Cystatin C and Kidney Injury Molecule-1 (KIM 1). At present, there is scarcity of prospective study on CI-AKI and role of biomarkers in critically ill medical or medical-surgical mixed ICU patients. The investigators plan to enroll about 100 ICU patients during 2 years, requiring computed tomography (CT) scans with parenteral administration of iodinated radiographic contrast for any diagnostic purposes as decided by the clinicians during the treatment of the patients. In this prospective observation study, the investigators want to analyse the role of plasma and urinary biomarkers in predicting CI-AKI in critically ill patients. Key Words: acute kidney injury, radiographic contrast, critically ill, biomarker

Conditions

Acute Kidney Injury

Keywords

acute kidney injury; radiographic contrast; critically ill; biomarker

Outcome Measures

Primary Outcomes (1)

• 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.

  Correlate levels of biomarkers in plasma and urine at different time interval in patients who develop contrast-induced acute kidney injury

  48 Hours after contrast exposure

Other Outcomes (1)

• Incidence of contrast induced-acute kidney injury (CI-AKI) in critically ill patients

  48 Hours after contrast exposure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All adult critically ill patients having normal renal function will be consider for inclusion in this study, who will require a contrast-enhanced CT scan of any organ system as decided by the treating clinician and also met study criteria as predefined.

You may not qualify if:

• 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

Sponsors & Collaborators

• Sanjay Gandhi Postgraduate Institute of Medical Sciences: lead

Study Sites (1)

Department of Critical Care Medicine, Sanjay Gandhi Postgraduate Institute of Medical Sciences (SGPGIMS)

Lucknow, Uttar Pradesh, 226014, India

Location

MeSH Terms

Conditions

Acute Kidney Injury; Critical Illness

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Mohan Gurjar, MD

  Sanjay Gandhi Postgraduate Institute of Medical Sciences (SGPGIMS)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2015
• First Posted: April 30, 2015
• Study Start: May 6, 2015
• Primary Completion: May 8, 2017
• Study Completion: May 8, 2017
• Last Updated: May 25, 2017

Record last verified: 2017-05

Locations

IN (1)