Central Venous Pressure Guided Hydration Prevention for Contrast-Induced Nephropathy
Primary Purpose
Cardio-Renal Syndrome
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
hydration
Visipaque
0.9% sodium chloride fluid administration
5-French catheter
Sponsored by
About this trial
This is an interventional prevention trial for Cardio-Renal Syndrome focused on measuring contrast-induced nephropathy, hydration, Percutaneous coronary intervention
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.
Sites / Locations
- Chinese People's Liberation Army General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
CVP guided hydration
Control
Arm Description
The fluid rate was adjusted according to the CVP dynamically
The control group was hydrated at 1 mL/kg per h.
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
NCT ID
NCT02405377
First Posted
March 23, 2015
Last Updated
March 31, 2015
Sponsor
Chinese PLA General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02405377
Brief Title
Central Venous Pressure Guided Hydration Prevention for Contrast-Induced Nephropathy
Official Title
Chinese People's Liberation Army General Hospital
Study Type
Interventional
2. Study Status
Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
February 2014 (undefined)
Primary Completion Date
February 2015 (Actual)
Study Completion Date
February 2015 (Actual)
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. 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).
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.
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, Percutaneous coronary intervention
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
264 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CVP guided hydration
Arm Type
Experimental
Arm Description
The fluid rate was adjusted according to the CVP dynamically
Arm Title
Control
Arm Type
Active Comparator
Arm Description
The control group was hydrated at 1 mL/kg per h.
Intervention Type
Procedure
Intervention Name(s)
hydration
Intervention Description
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.
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
Device
Intervention Name(s)
5-French catheter
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dai Yun Chen, MD
Organizational Affiliation
Chinese PLA General Hospital
Official's Role
Study Chair
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
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
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
22230154
Citation
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.
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
22717305
Citation
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.
Results Reference
background
PubMed Identifier
25613017
Citation
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.
Results Reference
background
PubMed Identifier
24856027
Citation
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.
Results Reference
result
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
derived
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Central Venous Pressure Guided Hydration Prevention for Contrast-Induced Nephropathy
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