- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02405377
Central Venous Pressure Guided Hydration Prevention for Contrast-Induced Nephropathy
Chinese People's Liberation Army General Hospital
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Beijing
-
Peking, Beijing, China, 100853
- Chinese People's Liberation Army General Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
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: CVP guided hydration
The fluid rate was adjusted according to the CVP dynamically
|
All study participants received intra-arterial (320 mg I/ml; GE Healthcare)
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.
|
Active Comparator: Control
The control group was hydrated at 1 mL/kg per h.
|
All study participants received intra-arterial (320 mg I/ml; GE Healthcare)
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.
|
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
Sponsor
Investigators
- Study Chair: Dai Yun Chen, MD, Chinese PLA General hospital
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 14KMM02
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