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

The Optimal Hydration With Sodium Chloride in High Risk Patients Undergoing Coronary Angiography, Reduction of Risk of Contrast-associated Acute Kidney Injury After Cardiac Catheterization 2 (TIME RESCIND 2) Study

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.

Study Overview

• Status: Completed
• Conditions: Chronic Kidney Disease
• Intervention / Treatment: Other: Standard Hydration; Other: Simplified Hydration

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 Type: Interventional
• Enrollment (Actual): 1002
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 501080
      • Guangdong Provincial People's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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	Other: Standard Hydration; Sodium chloride hydration was set between 12 hours before coronary intervention (before contrast exposure during coronary angiography), continued during procedure, and 12 hours after procedure at 1 ml/kg/h (0.5 ml/kg/h For patients with congestive heart failure, New York Heart Association class>II, or LVEF < 35%). For patients weighing more than 80 kg, bolus and infusion rates are limited to calculated values for patients weighing 80 kg; Other Names: The control hydration group
Active Comparator: 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	Other: Simplified Hydration; Hydration with sodium chloride was set 1 hour before procedure (before contrast exposure during coronary angiography), continued during procedure, and 4 hours after procedure at 3ml/kg/h (1.5ml/kg/h For patients with congestive heart failure, New York Heart Association class>II, or LVEF <35%). For patients weighing more than 80 kg, bolus and infusion rates are limited to those calculated for patients weighing 80 kg.; Other Names: The simple hydration group

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants with Acute heart failure	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)	post-procedural during hospitalization, an average of 3 days
Contrast-associated acute kidney injury b	Defined as ≥0.5 mg/dL increase in serum creatinine from baseline during the first 48-72 hours after the procedure	72 hours
Contrast-associated acute kidney injury c	Defined as ≥10% increase in serum cystatin c from baseline during the first 24 hours after the procedure	24 hours
Contrast-associated acute kidney injury d	Defined as ≥50% or 0.3 mg/dL increase in serum creatinine from baseline during the first 48 hours after the procedure	48 hours
Contrast-associated acute kidney injury e	Defined as ≥0.3mg/dl increase in serum cystatin c from baseline during the first 24 hours after the procedure	24 hours
Major adverse clinical events	Including all-cause mortality, renal replacement therapy, nonfatal myocardial infarction, acute pulmonary edema, stroke, rehospitalization, bleeding	1 year
Change in eGFR a	Change in eGFR within 48-72 hours after procedure (calculated according to the simplified MDRD formula)	72 hours
Change in eGFR b	Change in eGFR within 48-72 hours after procedure (calculated according to the Cysc)	72 hours
Contrast-induced persistence kidney injury	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	3 months
Length of stay	Total length of hospital stay	an average of 7 days
Total hospitalization costs	Hospitalization expenses during hospitalization	an average of 7 days

Collaborators and Investigators

• Sponsor: Guangdong Provincial People's Hospital
• Collaborators: Peking University First Hospital; Xijing Hospital; Fudan University; Beijing Friendship Hospital; First Affiliated Hospital, Sun Yat-Sen University; West China Hospital; The First Affiliated Hospital of Zhengzhou University; Xuzhou Central Hospital; Wuhan Asia Heart Hospital; Second Xiangya Hospital of Central South University; Southern Medical University, China; Sichuan Provincial People's Hospital; Fujian Provincial Hospital; Jining Medical University; People's Hospital of Guangxi; First Affiliated Hospital of Guangxi Medical University; Xiamen Cardiovascular Hospital, Xiamen University; Tangshan Gongren Hospital; Maoming People's Hospital; Fuling Central Hospital of Chongqing City; The General Hospital of Northern Theater Command
• Investigators: Principal Investigator: Junbo Ge, MD, Fudan University; Study Chair: Jiyan Chen, MD, Guangdong Cardiovascular Institute, Guangdong Provincial People's Hospital; Study Director: Yong Liu, MD, Guangdong Cardiovascular Institute, Guangdong Provincial People's Hospital; Principal Investigator: Pingyan Chen, MS, Southern Medical University

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2015
• Primary Completion (Actual): December 1, 2021
• Study Completion (Actual): December 1, 2021

Study Registration Dates

• First Submitted: September 1, 2014
• First Submitted That Met QC Criteria: September 5, 2014
• First Posted (Estimate): September 8, 2014

Study Record Updates

• Last Update Posted (Actual): October 3, 2022
• Last Update Submitted That Met QC Criteria: September 29, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: Coronary angiography; Chronic kidney disease; Contrast-associated acute kidney injury; Intravenous hydration
• Additional Relevant MeSH Terms: Urologic Diseases; Renal Insufficiency; Kidney Diseases; Renal Insufficiency, Chronic
• Other Study ID Numbers: CSC20140818 (Other Identifier: Chinese Society of Cardiology)