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

NCT02718521 | Unknown DMC

• 1 other identifier: 16kds2
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

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).

Conditions

Cardio-Renal Syndrome

Keywords

contrast-induced nephropathy; hydration therapy combined with intravenous infusion of isosorbide; percutaneous coronary intervention

Outcome Measures

Primary Outcomes (1)

• Contrast induced nephropathy postoperation

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

  7 days

Secondary Outcomes (1)

• Composite measure of dialysis or main cardiovascular events

  90 days

Study Arms (2)

Hydration Therapy Combined With Isosorbide Dinitrate

EXPERIMENTAL

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; Drug: Visipaque; Drug: 0.9% sodium chloride fluid administration; Drug: isosorbide dinitrate

Conventional hydration group

ACTIVE COMPARATOR

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; Drug: Visipaque; Drug: 0.9% sodium chloride fluid administration

Interventions

Hydration Combined With Intravenous Infusion of Isosorbide Dinitrate PROCEDURE

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

Conventional hydration group; Hydration Therapy Combined With Isosorbide Dinitrate

Visipaque DRUG

All study participants received intra-arterial (320 mg I/ml; GE Healthcare)

Conventional hydration group; Hydration Therapy Combined With Isosorbide Dinitrate

0.9% sodium chloride fluid administration DRUG

Conventional hydration group; Hydration Therapy Combined With Isosorbide Dinitrate

isosorbide dinitrate DRUG

Hydration Therapy Combined With Isosorbide Dinitrate

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chinese PLA General Hospital: lead

Study Sites (1)

Chinese People's Liberation Army General Hospital

Beijing, Beijing Municipality, 100853, China

Location

Related Publications (7)

• 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.

  PMID: 23045301 BACKGROUND

• 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.

  PMID: 16788132 BACKGROUND

• 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.

  PMID: 24393347 BACKGROUND

• 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.

  PMID: 15464318 BACKGROUND

• 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.

  PMID: 22535561 BACKGROUND

• 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.

  PMID: 26685074 BACKGROUND

• 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.

  PMID: 30054906 DERIVED

MeSH Terms

Conditions

Cardio-Renal Syndrome

Interventions

iodixanol; Isosorbide Dinitrate

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Heart Failure; Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Isosorbide; Sorbitol; Sugar Alcohols; Alcohols; Organic Chemicals; Carbohydrates

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate attending doctor

Study Record Dates

• First Submitted: March 19, 2016
• First Posted: March 24, 2016
• Study Start: March 1, 2016
• Primary Completion: March 1, 2017
• Study Completion: April 1, 2017
• Last Updated: March 24, 2016

Record last verified: 2016-03

Locations

CN (1)