Central Venous Pressure Guided Hydration Prevention for Contrast-Induced Nephropathy

NCT02405377 | Completed DMC

• 1 other identifier: 14KMM02
• Study Type: interventional
• Target: 264
• 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. It is important to make an individual hydration protocol for patients with dysfunction of heart and renal to reduce the incidence rate of CIN. 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=132) or the central venous pressure (CVP) guided hydration (n=132).

Conditions

Cardio-Renal Syndrome

Keywords

contrast-induced nephropathy; hydration; 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)

CVP guided hydration

EXPERIMENTAL

The fluid rate was adjusted according to the CVP dynamically

Procedure: hydration; Drug: Visipaque; Drug: 0.9% sodium chloride fluid administration; Device: 5-French catheter

Control

ACTIVE COMPARATOR

The control group was hydrated at 1 mL/kg per h.

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

Interventions

hydration PROCEDURE

Before the coronary procedures, investigators used the same 0.9% sodium chloride for hydration in all patients. Investigator monitored the central venous pressure (CVP) by placing an 5-French catheter in the jugular vein in the intervention group, and administration fluid rate was adjusted according to the CVP as follows: 3 ml/kg/h for CVP lower than 6 mmHg, 1.5 ml/kg/h for pressure of 6-12 mmHg, and 1ml/kg/h for pressure higher than 12 mmHg. The control group was hydrated with 0.9% sodium chloride at 1 ml/kg/h, continued for the duration of 12 h post-procedure in both groups. Thus, both study groups received intravenous fluids for the same duration but at different rates. All study participants received intra-arterial Visipaque(320 mg I/ml; GE Healthcare) iso-osmolar contrast medium.

CVP guided hydration; Control

Visipaque DRUG

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

CVP guided hydration; Control

0.9% sodium chloride fluid administration DRUG

CVP guided hydration; Control

5-French catheter DEVICE

CVP guided hydration

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 (8)

• 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

• 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

• Marenzi G, Ferrari C, Marana I, Assanelli E, De Metrio M, Teruzzi G, Veglia F, Fabbiocchi F, Montorsi P, Bartorelli AL. Prevention of contrast nephropathy by furosemide with matched hydration: the MYTHOS (Induced Diuresis With Matched Hydration Compared to Standard Hydration for Contrast Induced Nephropathy Prevention) trial. JACC Cardiovasc Interv. 2012 Jan;5(1):90-7. doi: 10.1016/j.jcin.2011.08.017.

  PMID: 22230154 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

• Torigoe K, Tamura A, Watanabe T, Kadota J. 20-Hour preprocedural hydration is not superior to 5-hour preprocedural hydration in the prevention of contrast-induced increases in serum creatinine and cystatin C. Int J Cardiol. 2013 Sep 1;167(5):2200-3. doi: 10.1016/j.ijcard.2012.05.122. Epub 2012 Jun 19.

  PMID: 22717305 BACKGROUND

• Duan N, Zhao J, Li Z, Dong P, Wang S, Zhao Y, Wang L, Wang H. Furosemide with saline hydration for prevention of contrast-induced nephropathy in patients undergoing coronary angiography: a meta-analysis of randomized controlled trials. Med Sci Monit. 2015 Jan 23;21:292-7. doi: 10.12659/MSM.892446.

  PMID: 25613017 BACKGROUND

• Brar SS, Aharonian V, Mansukhani P, Moore N, Shen AY, Jorgensen M, Dua A, Short L, Kane K. Haemodynamic-guided fluid administration for the prevention of contrast-induced acute kidney injury: the POSEIDON randomised controlled trial. Lancet. 2014 May 24;383(9931):1814-23. doi: 10.1016/S0140-6736(14)60689-9.

  PMID: 24856027 RESULT

• 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 DERIVED

MeSH Terms

Conditions

Cardio-Renal Syndrome

Interventions

iodixanol

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

Study Officials

• Dai Yun Chen, MD

  Chinese PLA General Hospital

  STUDY CHAIR

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: Attending doctor

Study Record Dates

• First Submitted: March 23, 2015
• First Posted: April 1, 2015
• Study Start: February 1, 2014
• Primary Completion: February 1, 2015
• Study Completion: February 1, 2015
• Last Updated: April 1, 2015

Record last verified: 2015-03

Locations

CN (1)