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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1002 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-30

Study Completion Date

2021-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Chronic Kidney Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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

Group Type ACTIVE_COMPARATOR

Standard Hydration

Intervention Type OTHER

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

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

Group Type ACTIVE_COMPARATOR

Simplified Hydration

Intervention Type OTHER

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.

Interventions

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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

Intervention Type 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.

Intervention Type OTHER

Other Intervention Names

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The control hydration group The simple hydration group

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No