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

Chronic Kidney Disease Clinical Trial

— TIME  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02232997
• Other study ID #: CSC20140818
• Secondary ID: CSC20140818
• Status: Completed
• Phase: N/A
• Start date: April 2015
• Est. completion date: December 2021

Study information

• Verified date: September 2022
• Source: Guangdong Provincial People's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1002
• Est. completion date: December 2021
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

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
• 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.

Locations

Country	Name	City	State
China	Guangdong Provincial People's Hospital	Guangzhou	Guangdong

Sponsors (22)

Lead Sponsor

Collaborator

Guangdong Provincial People's Hospital

Beijing Friendship Hospital, First Affiliated Hospital of Guangxi Medical University, First Affiliated Hospital, Sun Yat-Sen University, Fudan University, Fujian Provincial Hospital, Fuling Central Hospital of Chongqing City, Jining Medical University, Maoming People's Hospital, China, Peking University First Hospital, People's Hospital of Guangxi, Second Xiangya Hospital of Central South University, Sichuan Provincial People's Hospital, Southern Medical University, China, Tangshan Gongren Hospital, The First Affiliated Hospital of Zhengzhou University, The General Hospital of Northern Theater Command, West China Hospital, Wuhan Asia Heart Hospital, Xiamen Cardiovascular Hospital, Xiamen University, Xijing Hospital, Xuzhou Central Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Major adverse clinical events	Including all-cause mortality, renal replacement therapy, nonfatal myocardial infarction, acute pulmonary edema, stroke, rehospitalization, bleeding	1 year
Secondary	Change in eGFR a	Change in eGFR within 48-72 hours after procedure (calculated according to the simplified MDRD formula)	72 hours
Secondary	Change in eGFR b	Change in eGFR within 48-72 hours after procedure (calculated according to the Cysc)	72 hours
Secondary	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
Secondary	Length of stay	Total length of hospital stay	an average of 7 days
Secondary	Total hospitalization costs	Hospitalization expenses during hospitalization	an average of 7 days