The Effect of the Hydroxyethyl Starch on Kidney Injury in Pediatric Cardiac Surgery

June 22, 2017 updated by: Jin-Tae Kim, Seoul National University Hospital
The investigator will evaluate the influence of colloid administration on postoperative acute kidney injury in pediatric patients undergoing cardiac surgery under cardiopulmonary bypass.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The investigator will randomly divide pediatric patients aged less than 7 years old into crystalloid and colloid groups. Crystalloid group receive only crystalloid, and colloid group receive hydroxyethyl starch (HES, 130/0.4). The maximum volume of HES is limited less than 30 ml/kg. The same transfusion protocol will be applied in both groups. From the day of operation to postoperative 7 days, glomerular filtration rate (GFR), serum creatinin level (Cr) will be checked. Acute kidney injury (AKI) is defined when there is more than 50% increase in Cr when compared to baseline level. The investigator will compare the clinical outcomes including AKI between two groups.

Study Type

Interventional

Enrollment (Actual)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 7 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Children aged less than 7 years old
  • American Society of Anesthesiology (ASA) physical status 1-3

Exclusion Criteria:

  • Preoperative creatinine > 1.5mg/dl
  • History of dialysis
  • Liver function abnormality
  • Diabetes Mellitus
  • History of allergic reaction
  • Coagulation abnormality

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Crystalloid group
Crystalloid group receive only crystalloid for intravenous volume expansion. The same transfusion protocol is applied in both groups.
Drug: Crystalloid
normal saline administration for volume expansion in hypovolemic status
Other Names:
  • normal saline
Active Comparator: Colloid group
Colloid group receive colloid preferentially for intravenous volume expansion, until 30 ml/kg. The same transfusion protocol is applied in both groups.
Drug: Colloid
HES 130/0.4 administration for volume expansion in hypovolemic status
Other Names:
  • HES 130/0.4

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Acute Kidney Injury
Time Frame: From the day of surgery to postoperative 7 days
From the day of surgery to postoperative 7 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Blood loss
Time Frame: From the day of surgery to postoperative 7 days
From the day of surgery to postoperative 7 days
Transfusion amount
Time Frame: From the day of surgery to postoperative 7 days
From the day of surgery to postoperative 7 days
Mechanical ventilation time
Time Frame: From the day of surgery to postoperative 7 days
From the day of surgery to postoperative 7 days
Length of ICU stay
Time Frame: From the day of surgery to postoperative 7 days
From the day of surgery to postoperative 7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2015

Primary Completion (Actual)

February 1, 2016

Study Completion (Actual)

March 1, 2016

Study Registration Dates

First Submitted

November 3, 2015

First Submitted That Met QC Criteria

November 4, 2015

First Posted (Estimate)

November 6, 2015

Study Record Updates

Last Update Posted (Actual)

June 26, 2017

Last Update Submitted That Met QC Criteria

June 22, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H1507-061-687

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Locations

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