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Completed

NCT Number: NCT02232997

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

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, 501080, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Standard Hydration

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

Other names: The control hydration group

Simplified Hydration

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.

Other names: The simple hydration group

Primary outcomes

  1. Contrast-associated acute kidney injury a

    Time frame: 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 outcomes

  1. Number of Participants with Acute heart failure

    Time frame: 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)

  2. Contrast-associated acute kidney injury b

    Time frame: 72 hours

    Defined as ≥0.5 mg/dL increase in serum creatinine from baseline during the first 48-72 hours after the procedure

  3. Contrast-associated acute kidney injury c

    Time frame: 24 hours

    Defined as ≥10% increase in serum cystatin c from baseline during the first 24 hours after the procedure

  4. Contrast-associated acute kidney injury d

    Time frame: 48 hours

    Defined as ≥50% or 0.3 mg/dL increase in serum creatinine from baseline during the first 48 hours after the procedure

  5. Contrast-associated acute kidney injury e

    Time frame: 24 hours

    Defined as ≥0.3mg/dl increase in serum cystatin c from baseline during the first 24 hours after the procedure

  6. Major adverse clinical events

    Time frame: 1 year

    Including all-cause mortality, renal replacement therapy, nonfatal myocardial infarction, acute pulmonary edema, stroke, rehospitalization, bleeding

  7. Change in eGFR a

    Time frame: 72 hours

    Change in eGFR within 48-72 hours after procedure (calculated according to the simplified MDRD formula)

  8. Change in eGFR b

    Time frame: 72 hours

    Change in eGFR within 48-72 hours after procedure (calculated according to the Cysc)

  9. Contrast-induced persistence kidney injury

    Time frame: 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

  10. Length of stay

    Time frame: an average of 7 days

    Total length of hospital stay

  11. Total hospitalization costs

    Time frame: an average of 7 days

    Hospitalization expenses during hospitalization

Sponsors and collaborators

Lead sponsor

Guangdong Provincial People's Hospital

Other

Collaborators

  • 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
  • Peking University First Hospital
  • People's Hospital of Guangxi Zhuang Autonomous Region
  • 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

Registry information

Official study 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

Acronym: TIME

Important dates

Study start
2015
Primary completion
2021
Study completion
2021
First posted
Sep 8, 2014
Registry last updated
Oct 3, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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