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Central Venous Pressure Guided Hydration Prevention for Contrast-Induced Nephropathy

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ClinicalTrials.gov Identifier: NCT02405377
Recruitment Status : Completed
First Posted : April 1, 2015
Last Update Posted : April 1, 2015
Sponsor:
Information provided by (Responsible Party):
Qian geng, Chinese PLA General Hospital

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).

Condition or disease Intervention/treatment Phase
Cardio-Renal Syndrome Procedure: hydration Drug: Visipaque Drug: 0.9% sodium chloride fluid administration Device: 5-French catheter Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 264 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Chinese People's Liberation Army General Hospital
Study Start Date : February 2014
Actual Primary Completion Date : February 2015
Actual Study Completion Date : February 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

Arm Intervention/treatment
Experimental: CVP guided hydration
The fluid rate was adjusted according to the CVP dynamically
Procedure: hydration
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.

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

Drug: 0.9% sodium chloride fluid administration
Device: 5-French catheter
Active Comparator: Control
The control group was hydrated at 1 mL/kg per h.
Procedure: hydration
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.

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

Drug: 0.9% sodium chloride fluid administration



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Composite measure of dialysis or main cardiovascular events [ Time Frame: 90 days ]
    dialysis, myocardial infarction, heart failure and all-cause death



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02405377


Locations
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China, Beijing
Chinese People's Liberation Army General Hospital
Peking, Beijing, China, 100853
Sponsors and Collaborators
Chinese PLA General Hospital
Investigators
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Study Chair: Dai Yun Chen, MD Chinese PLA General Hospital

Publications of Results:
Other Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Qian geng, Attending doctor, Chinese PLA General Hospital
ClinicalTrials.gov Identifier: NCT02405377     History of Changes
Other Study ID Numbers: 14KMM02
First Posted: April 1, 2015    Key Record Dates
Last Update Posted: April 1, 2015
Last Verified: March 2015
Keywords provided by Qian geng, Chinese PLA General Hospital:
contrast-induced nephropathy
hydration
Percutaneous coronary intervention
Additional relevant MeSH terms:
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Cardio-Renal Syndrome
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Heart Failure
Heart Diseases
Cardiovascular Diseases