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Simplified Rapid Hydration in Preventing CA-AKI Among Patients With Chronic Kidney Disease (TIME)

G

Guangdong Provincial People's Hospital (Guangdong Provincial Academy of Medical Sciences)

Status

Completed

Conditions

Chronic Kidney Disease

Treatments

Other: Simplified Hydration
Other: Standard Hydration

Study type

Interventional

Funder types

Other

Identifiers

NCT02232997
CSC20140818 (Other Identifier)

Details and patient eligibility

About

No well-defined protocols exist to guide fluid administration for prevention of contrast-associated acute kidney injury in high risk patients. The investigators will compare long term hydration at routine speed(12h before and after procedure at 1ml/kg/h) with short term hydration at high speed(1h before and 4h after procedure at 3ml/kg/h) to verify our hypothesis that the short term hydration may not be inferior to the long one.

Full description

No well-defined protocols exist to guide fluid administration for prevention of contrast-associated acute kidney injury in high risk patients undergoing coronary angiography. Long term hydration at routine speed(12h before and after procedure at 1ml/kg/h), as the most recommended adequate hydration, has been carried out to prevent contrast-associated acute kidney injury in lots of clinical trials. Base on the data in the POSEIDON randomized controlled trial with hemodynamic-guided fluid administration, short term hydration at high speed(1h before and 4h after procedure at 3ml/kg/h) may not be inferior to the classic long term hydration, the speed should be reduced half of the intended speed in all the patients. We hypothesized short term hydration may not be inferior to the long one to reduced significantly the hospital stay and healthy cost.

Enrollment

1,002 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • ≥18 years of age;
  • Written informed consent;
  • Candidates scheduled for coronary intervention (angiography and/or coronary intervention);
  • Patients with chronic renal insufficiency, the baseline estimated glomerular filtration rate (eGFR) was 15-60 mL/min / 1.73 m²
  • At least one risk factor (age>75 years, medical history of diabetes mellitus or hypertension, congestive heart failure [NYHA class >II or history of acute pulmonary edema]);

Exclusion criteria

  • End-stage renal failure or heart/renal transplantation;
  • History of exposure to contrast medium or acute infectious diseases within 48 hours prior to the procedure;
  • Acute decompensated heart failure;
  • Left ventricular thrombus;
  • Allergy to contrast agent;
  • Pregnancy or lactation;
  • Malignant tumour or life expectancy <1 year;
  • Pre-procedural receipt of NSAIDs (except Asprin), aminoglycosides, cyclosporine or cisplatin in the past 48 h;
  • Severe valve disease or elective undergoing surgery.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

1,002 participants in 2 patient groups

Standard Hydration
Active Comparator group
Description:
Standard long-term hydration, i.e. hydrated with normal saline 12 hours before and 12 hours after coronary intervention at a rate of 1 ml/kg/h
Treatment:
Other: Standard Hydration
Simplified Hydration
Active Comparator group
Description:
Rapid short-term hydration, i.e. hydrated with normal saline from 1 hour before to 4 hours after coronary intervention at a rate of 3 ml/kg/h
Treatment:
Other: Simplified Hydration

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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