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

Not Applicable

Completed

• Conditions: Chronic Kidney Disease
• Interventions: Other: Standard Hydration; Other: Simplified Hydration

• Registration Number: NCT02232997
• Lead Sponsor: Guangdong Provincial People's Hospital

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2014-09-01
• Study First Submitted QC: 2014-09-05
• Study First Posted: 2014-09-08
• Study Start: 2015-04
• Primary Completion: 2021-12
• Study Completion: 2021-12
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-29
• Last Update Posted: 2022-10-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1002

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]);

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard Hydration	Standard Hydration	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
Simplified Hydration	Simplified Hydration	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

Primary Outcome Measures

Name	Time	Method
Contrast-associated acute kidney injury a	72 hours	Defined as ≥25% or 0.5 mg/dL absolute increase in serum creatinine from baseline during the first 48-72 hours after the procedure

Secondary Outcome Measures

Name	Time	Method
Length of stay	an average of 7 days	Total length of hospital stay
Number of Participants with Acute heart failure	post-procedural during hospitalization, an average of 3 days	Defined as signs/symptoms of heart congestion and/or hypoperfusion by physical examination and auxiliary examination such as ECG, chest X-ray, laboratory assessment (biomarkers and echocardiography)
Major adverse clinical events	1 year	Including all-cause mortality, renal replacement therapy, nonfatal myocardial infarction, acute pulmonary edema, stroke, rehospitalization, bleeding
Contrast-associated acute kidney injury b	72 hours	Defined as ≥0.5 mg/dL increase in serum creatinine from baseline during the first 48-72 hours after the procedure
Contrast-associated acute kidney injury d	48 hours	Defined as ≥50% or 0.3 mg/dL increase in serum creatinine from baseline during the first 48 hours after the procedure
Contrast-associated acute kidney injury c	24 hours	Defined as ≥10% increase in serum cystatin c from baseline during the first 24 hours after the procedure
Contrast-associated acute kidney injury e	24 hours	Defined as ≥0.3mg/dl increase in serum cystatin c from baseline during the first 24 hours after the procedure
Change in eGFR a	72 hours	Change in eGFR within 48-72 hours after procedure (calculated according to the simplified MDRD formula)
Contrast-induced persistence kidney injury	3 months	Defined as residual impairment of renal function indicated by a \>25% reduction in creatinine clearance in comparison with the baseline value or dialysis requirement at 3 months
Change in eGFR b	72 hours	Change in eGFR within 48-72 hours after procedure (calculated according to the Cysc)
Total hospitalization costs	an average of 7 days	Hospitalization expenses during hospitalization

Trial Locations

Locations (1)

Guangdong Provincial People's Hospital; 🇨🇳 Guangzhou, Guangdong, China