Central Venous Pressure Guided Hydration Prevention for Contrast-Induced Nephropathy
Information source: Chinese PLA General Hospital
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Cardio-Renal Syndrome
Intervention: hydration (Procedure); Visipaque (Drug); 0.9% sodium chloride fluid administration (Drug); 5-French catheter (Device)
Phase: N/A
Status: Completed
Sponsored by: Chinese PLA General Hospital Official(s) and/or principal investigator(s): Dai Yun Chen, MD, Study Chair, Affiliation: Chinese PLA General Hospital
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).
Clinical Details
Official title: Chinese People's Liberation Army General Hospital
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Primary outcome: Contrast induced nephropathy postoperation
Secondary outcome: Composite measure of dialysis or main cardiovascular events
Detailed description:
Investigators enrolled 264 patients from February 2014 to February 2015, the principal
inclusion criterion included CHF: left ventricular eject fraction (LVEF) <= 50%; moderate to
severe 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 CVP guided therapy or a standard hydration administration protocol.
Investigators used the same fluid type commercially available 0. 9% sodium chloride in all
patients. Investigators monitored the CVP by placing an 5-French catheter in the jugular
vein. Investigators recorded the CVP with commercially available haemodynamic monitoring
software. In the CVP guided group the 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 at 1 mL/kg per h.
The fluid rate was set at the start of the procedure (before contrast exposure). 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.
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 80 Years.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Chinese People's Liberation Army General Hospital, Peking, Beijing 100853, China
Additional Information
Related publications: 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. 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. 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. 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. 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. 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.
Starting date: February 2014
Last updated: March 31, 2015
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