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NCT Number: NCT02405377

Central Venous Pressure Guided Hydration Prevention for Contrast-Induced Nephropathy

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).

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chinese People's Liberation Army General Hospital

Beijing, Beijing Municipality, 100853, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Visipaque

Drug

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

0.9% sodium chloride fluid administration

Drug

5-French catheter

Device

Primary outcomes

  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 outcomes

  1. Composite measure of dialysis or main cardiovascular events

    Time frame: 90 days

    dialysis, myocardial infarction, heart failure and all-cause death

Sponsors and collaborators

Lead sponsor

Chinese PLA General Hospital

Other

Registry information

Official study title

Chinese People's Liberation Army General Hospital

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Apr 1, 2015
Registry last updated
Apr 1, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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