Adequate Hydration Therapy Combined With Intravenous Infusion of Isosorbide Dinitrate Prevention for CIN

March 19, 2016 updated by: Qian geng, Chinese PLA General Hospital

Chinese People's Liberation Army General Hospital

Patients at moderate and high risk for contrast induced nephropathy (CIN) should receive sufficient hydration before application of contrast to prevent CIN, but hydration could obviously increase the preload for congestive heart failure (CHF) patients. Isosorbide Dinitrate could reduce cardiac preload and afterload by expanding vein and artery.so adequate hydration therapy combined with intravenous infusion of isosorbide dinitrate could better prevent contrast-induced nephropathy theoretically.This prospective, randomized, double-blind, comparative clinical trial randomly selected 264 patients with estimated glomerular filtration rate, (eGFR) <60 ml/min per 1.73 m2 and CHF undergoing coronary angiography to receive either the convention hydration (n=200) or the hydration therapy combined with intravenous infusion of isosorbide dinitrate(n=200).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Investigators enroll 400 patients from February 2016 to February 2017, the principal inclusion criterion included CHF: left ventricular eject fraction (LVEF) <= 50%; moderate to severe chronic kidney disease(CKD) was diagnosed as an eGFR 15 to 59 mL/min per 1.73 m2, calculated via the abbreviated Modification of Diet in Renal Disease (MDRD) study equation from SCr obtained within 72 hours of enrollment, patients were scheduled to undergo diagnostic cardiac angiography or percutaneous coronary interventions. We randomly assigned eligible patients in a 1:1 ratio to either the hydration therapy combined with intravenous infusion of isosorbide dinitrate or a standard hydration administration protocol. hydration therapy combined with intravenous infusion of isosorbide dinitrate refer to give intravenous infusion of isosorbide dinitrate on the basis of fully hydration to reduce cardiac preload.afterload and increase the the tolerance degreen of hydration in chronic heart failure patients. both study groups received intravenous fluids for the same hydration dose. All study participants received intra-arterial Visipaque(320 mg I/ml; GE Healthcare) iso-osmolar contrast medium.

Primary end point of the study was the incidence of CIN: The median peak increase in serum creatinine concentration between day 0 (when contrast was administered) and day 7. Definition of CIN was an absolute increase in serum creatinine (SCr) >0.5 mg/dl or a relative increase >25% compared to baseline SCr. Definition of non-Q-wave myocardial infarction was a creatine kinase-myocardial band enzyme elevation 3 times the upper normal value without new Q waves on the electrocardiogram. Definition of Q-wave myocardial infarction was presence of new pathologic Q waves on an electrocardiogram in conjunction with an elevation in creatine kinase greater than 3 times the normal value. All adverse clinical events as well as study end points were monitored and adjudicated by the independent event committee. Each patient was contacted in every week after administration of the contrast, investigated if dialysis or main cardiovascular events (myocardial infarction,acute heart failure and death), and record any adverse events.

Study Type

Interventional

Enrollment (Anticipated)

400

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Peking, Beijing, China, 100853
        • Chinese People's Liberation Army General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. congestive heart failure: objective evidences for decreased left ventricular eject fraction (LVEF) <= 50%;
  2. moderate to severe chronic kidney disease was defined as an eGFR 15 to 59 mL/min per 1.73 m2, calculated via the abbreviated Modification of Diet in Renal Disease (MDRD) study equation from SCr obtained within 72 hours of enrollment;
  3. patients were scheduled to undergo diagnostic cardiac angiography or percutaneous coronary interventions.

Exclusion Criteria:

  1. hemodialysis-dependent patients;
  2. complicated with severe short-term progressive disease;
  3. Patients < 18 years;
  4. pregnancy;
  5. emergency cardiac catheterisation (eg, primary percutaneous coronary intervention for ST-segment elevation myocardial infarction);
  6. exposure to radiographic contrast media within the previous 7 days;
  7. acute decompensated heart failure.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Hydration Therapy Combined With Isosorbide Dinitrate
Intravenous Infusion of Isosorbide Dinitrate 2mg/h combined with normal saline 1 ml/kg·h 6 hours before angiography and 12 hours after angiography
Procedure: Hydration Combined With Intravenous Infusion of Isosorbide Dinitrate
Before the coronary procedures, investigators used the same 0.9% sodium chloride for hydration conbined with isosorbide dinitrate in all patients 6 hours before angiography and 12 hours after angiography
Drug: Visipaque
All study participants received intra-arterial (320 mg I/ml; GE Healthcare)
Drug: 0.9% sodium chloride fluid administration
Drug: isosorbide dinitrate
Active Comparator: Conventional hydration group
normal saline 0.5 ml/kg·h 6 hours before angiography and 12 hours after angiography
Procedure: Hydration Combined With Intravenous Infusion of Isosorbide Dinitrate
Before the coronary procedures, investigators used the same 0.9% sodium chloride for hydration conbined with isosorbide dinitrate in all patients 6 hours before angiography and 12 hours after angiography
Drug: Visipaque
All study participants received intra-arterial (320 mg I/ml; GE Healthcare)
Drug: 0.9% sodium chloride fluid administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Contrast induced nephropathy postoperation
Time Frame: 7 days
a peak serum creatinine increase of either 0.5 mg/dl or 25% from day 0 through day 7
7 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Composite measure of dialysis or main cardiovascular events
Time Frame: 90 days
dialysis, myocardial infarction, heart failure and all-cause death
90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese PLA General Hospital

Publications and helpful links

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General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2016

Primary Completion (Anticipated)

March 1, 2017

Study Completion (Anticipated)

April 1, 2017

Study Registration Dates

First Submitted

March 19, 2016

First Submitted That Met QC Criteria

March 19, 2016

First Posted (Estimate)

March 24, 2016

Study Record Updates

Last Update Posted (Estimate)

March 24, 2016

Last Update Submitted That Met QC Criteria

March 19, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16kds2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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