Rosuvastatin Prevent Contrast Induced Acute Kidney Injury in Patients With Diabetes

The number of cardiac angiography and percutaneous coronary interventions (PCI) has increased steadily in recent years. This has resulted in the increasing incidence of contrast-induced acute kidney injury (CIAKI). Major risk factors for CIAKI include older age, diabetes mellitus (DM), chronic kidney disease(CKD), the concurrent use of nephrotoxic drugs, hemodynamic instability, etc. Importantly, DM appears to act as a risk multiplier, meaning that in a patient with CKD it amplifies the risk of CIAKI.

The aim of this multicenter prospective, randomized, controlled study is to evaluate whether statins treatment during the perioperative period would reduce the risk of CIAKI in a high-risk population of patients with both type 2 diabetes mellitus (T2DM) and CKD undergoing coronary angiography or noncoronary angiography, and evaluate the influence of such potential benefit on short-term outcome.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Diabetes Mellitus Chronic Disease Chronic Kidney Disease Disease Attributes Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Kidney Diseases Male Urogenital Diseases Metabolic Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

General Hospital Of The Second Artillery Force of the PLA, Beijing, Beijing Municipality, China

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Planned diagnostic coronary or peripheral artery angiography
T2DM
CKD stages 2 and 3, eGFR 30 to 89ml/min per 1.73m2
Statin naive, or not on statin treatment for at least 14 days
Withdrawal metformin or aminophylline for 48h before angiography
Total iodixanol volume

Exclusion criteria

Hypersensitivity to iodine-containing compounds and statins
Type 1 diabetes mellitus
Ketoacidosis
Lactic acidosis
CKD stages 1,4 or 5 (eGFR≥90ml/min per 1.73m2 or eGFR<30ml/min per 1.73m2)
STEMI
NYHA class IV or hemodynamic instability
Administration of any iodinated CM within 14 days before randomization
LDL-C<1.82mmol/L（70mg/dL）
Hepatic dysfunction (ALT 3 times greater than upper normal limit)
Thyreoid insufficiency
renal artery Stenosis(unilateral >70％ or bilateral stenosis>50％)

Treatment and study plan

Rosuvastatin

Drug

rosuvastatin

Primary outcomes

An absolute increase in SCr >=0.5mg/dL（>=44.2μmmol/L）or a >= 25% increase in SCr from baseline to 72h after the procedure

Time frame: 72 h

Secondary outcomes

The composite of hospitalization for aggravated renal function, acute renal failure, dialysis or hemofiltration, aggravated at least 1 class of heart function, acute left ventricular failure or death from all causes.

Time frame: 30 d

Sponsors and collaborators

Lead sponsor

Shenyang Northern Hospital

Other

Registry information

Official study title

Multicenter Randomized Controlled Study of Rosuvastatin for Prevention of Contrast Induced Acute Kidney Injury in Patients With Diabetes and Slight to Moderate Renal Insufficient

Acronym: TRACK-D

Important dates

Study start: 2008
Primary completion: 2011
Study completion: 2011
First posted: Nov 6, 2008
Registry last updated: Apr 10, 2013

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