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

Primary Purpose

Cardio-Renal Syndrome

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Hydration Combined With Intravenous Infusion of Isosorbide Dinitrate
Visipaque
0.9% sodium chloride fluid administration
isosorbide dinitrate
Sponsored by
Chinese PLA General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cardio-Renal Syndrome focused on measuring contrast-induced nephropathy, hydration therapy combined with intravenous infusion of isosorbide, percutaneous coronary intervention

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Chinese People's Liberation Army General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Hydration Therapy Combined With Isosorbide Dinitrate

Conventional hydration group

Arm Description

Intravenous Infusion of Isosorbide Dinitrate 2mg/h combined with normal saline 1 ml/kg·h 6 hours before angiography and 12 hours after angiography

normal saline 0.5 ml/kg·h 6 hours before angiography and 12 hours after angiography

Outcomes

Primary Outcome Measures

Contrast induced nephropathy postoperation
a peak serum creatinine increase of either 0.5 mg/dl or 25% from day 0 through day 7

Secondary Outcome Measures

Composite measure of dialysis or main cardiovascular events
dialysis, myocardial infarction, heart failure and all-cause death

Full Information

First Posted
March 19, 2016
Last Updated
March 19, 2016
Sponsor
Chinese PLA General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02718521
Brief Title
Adequate Hydration Therapy Combined With Intravenous Infusion of Isosorbide Dinitrate Prevention for CIN
Official Title
Chinese People's Liberation Army General Hospital
Study Type
Interventional

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Unknown status
Study Start Date
March 2016 (undefined)
Primary Completion Date
March 2017 (Anticipated)
Study Completion Date
April 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese PLA General Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardio-Renal Syndrome
Keywords
contrast-induced nephropathy, hydration therapy combined with intravenous infusion of isosorbide, percutaneous coronary intervention

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Hydration Therapy Combined With Isosorbide Dinitrate
Arm Type
Experimental
Arm Description
Intravenous Infusion of Isosorbide Dinitrate 2mg/h combined with normal saline 1 ml/kg·h 6 hours before angiography and 12 hours after angiography
Arm Title
Conventional hydration group
Arm Type
Active Comparator
Arm Description
normal saline 0.5 ml/kg·h 6 hours before angiography and 12 hours after angiography
Intervention Type
Procedure
Intervention Name(s)
Hydration Combined With Intravenous Infusion of Isosorbide Dinitrate
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Visipaque
Intervention Description
All study participants received intra-arterial (320 mg I/ml; GE Healthcare)
Intervention Type
Drug
Intervention Name(s)
0.9% sodium chloride fluid administration
Intervention Type
Drug
Intervention Name(s)
isosorbide dinitrate
Primary Outcome Measure Information:
Title
Contrast induced nephropathy postoperation
Description
a peak serum creatinine increase of either 0.5 mg/dl or 25% from day 0 through day 7
Time Frame
7 days
Secondary Outcome Measure Information:
Title
Composite measure of dialysis or main cardiovascular events
Description
dialysis, myocardial infarction, heart failure and all-cause death
Time Frame
90 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: congestive heart failure: objective evidences for decreased left ventricular eject fraction (LVEF) <= 50%; 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; patients were scheduled to undergo diagnostic cardiac angiography or percutaneous coronary interventions. Exclusion Criteria: hemodialysis-dependent patients; complicated with severe short-term progressive disease; Patients < 18 years; pregnancy; emergency cardiac catheterisation (eg, primary percutaneous coronary intervention for ST-segment elevation myocardial infarction); exposure to radiographic contrast media within the previous 7 days; acute decompensated heart failure.
Facility Information:
Facility Name
Chinese People's Liberation Army General Hospital
City
Peking
State/Province
Beijing
ZIP/Postal Code
100853
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
23045301
Citation
Chen Y, Hu S, Liu Y, Zhao R, Wang L, Fu G, He Q, Su X, Zheng Y, Qi X, Liu H, Wang J, Gao W, Wang M, Liu S, Zheng X, He B, Yang P, Zhou S, Gao C, Qiu C. Renal tolerability of iopromide and iodixanol in 562 renally impaired patients undergoing cardiac catheterisation: the DIRECT study. EuroIntervention. 2012 Nov 22;8(7):830-8. doi: 10.4244/EIJV8I7A126.
Results Reference
background
PubMed Identifier
16788132
Citation
Pannu N, Wiebe N, Tonelli M; Alberta Kidney Disease Network. Prophylaxis strategies for contrast-induced nephropathy. JAMA. 2006 Jun 21;295(23):2765-79. doi: 10.1001/jama.295.23.2765.
Results Reference
background
PubMed Identifier
24393347
Citation
Schilp J, de Blok C, Langelaan M, Spreeuwenberg P, Wagner C. Guideline adherence for identification and hydration of high-risk hospital patients for contrast-induced nephropathy. BMC Nephrol. 2014 Jan 6;15:2. doi: 10.1186/1471-2369-15-2.
Results Reference
background
PubMed Identifier
15464318
Citation
Mehran R, Aymong ED, Nikolsky E, Lasic Z, Iakovou I, Fahy M, Mintz GS, Lansky AJ, Moses JW, Stone GW, Leon MB, Dangas G. A simple risk score for prediction of contrast-induced nephropathy after percutaneous coronary intervention: development and initial validation. J Am Coll Cardiol. 2004 Oct 6;44(7):1393-9. doi: 10.1016/j.jacc.2004.06.068.
Results Reference
background
PubMed Identifier
22535561
Citation
Balemans CE, Reichert LJ, van Schelven BI, van den Brand JA, Wetzels JF. Epidemiology of contrast material-induced nephropathy in the era of hydration. Radiology. 2012 Jun;263(3):706-13. doi: 10.1148/radiol.12111667. Epub 2012 Apr 24.
Results Reference
background
PubMed Identifier
26685074
Citation
Qian G, Fu Z, Guo J, Cao F, Chen Y. Prevention of Contrast-Induced Nephropathy by Central Venous Pressure-Guided Fluid Administration in Chronic Kidney Disease and Congestive Heart Failure Patients. JACC Cardiovasc Interv. 2016 Jan 11;9(1):89-96. doi: 10.1016/j.jcin.2015.09.026. Epub 2015 Dec 9.
Results Reference
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PubMed Identifier
30054906
Citation
Qian G, Liu CF, Guo J, Dong W, Wang J, Chen Y. Prevention of contrast-induced nephropathy by adequate hydration combined with isosorbide dinitrate for patients with renal insufficiency and congestive heart failure. Clin Cardiol. 2019 Jan;42(1):21-25. doi: 10.1002/clc.23023. Epub 2019 Jan 7.
Results Reference
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Adequate Hydration Therapy Combined With Intravenous Infusion of Isosorbide Dinitrate Prevention for CIN

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