Central Venous Pressure Guided Hydration Prevention for Contrast-Induced Nephropathy
Condition: Cardio-Renal Syndrome
MeSH terms: Cardio-Renal Syndrome
Study type: Interventional

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.
    

Intervention name(s): hydration; Visipaque; 0.9% sodium chloride ﬂuid administration; 5-French catheter
Intervention type(s): Procedure; Drug; Drug; Device
Intervention description(s): 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.; All study participants received intra-arterial (320 mg I/ml; GE Healthcare)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: contrast-induced nephropathy; hydration; Percutaneous coronary intervention