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

Primary Purpose

Acute Kidney Injury

Status

Completed

Phase

Not Applicable

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Crystalloid

Colloid

About this trial

This is an interventional prevention trial for Acute Kidney Injury focused on measuring crystalloid, colloid, children, infant, cardiac surgery

Eligibility Criteria

undefined - 7 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Seoul national university hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Crystalloid group

Colloid group

Arm Description

Crystalloid group receive only crystalloid for intravenous volume expansion. The same transfusion protocol is applied in both groups.

Colloid group receive colloid preferentially for intravenous volume expansion, until 30 ml/kg. The same transfusion protocol is applied in both groups.

Outcomes

Primary Outcome Measures

Acute Kidney Injury

Secondary Outcome Measures

Blood loss

Transfusion amount

Mechanical ventilation time

Length of ICU stay

Full Information

NCT ID

NCT02599155

First Posted

November 3, 2015

Last Updated

June 22, 2017

Sponsor

Seoul National University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT02599155

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2017

Overall Recruitment Status

Completed

Study Start Date

November 2015 (undefined)

Primary Completion Date

February 2016 (Actual)

Study Completion Date

March 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Seoul National University Hospital

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The investigator will evaluate the influence of colloid administration on postoperative acute kidney injury in pediatric patients undergoing cardiac surgery under cardiopulmonary bypass.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Kidney Injury

Keywords

crystalloid, colloid, children, infant, cardiac surgery

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

200 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Crystalloid group

Arm Type

Placebo Comparator

Arm Description

Crystalloid group receive only crystalloid for intravenous volume expansion. The same transfusion protocol is applied in both groups.

Arm Title

Colloid group

Arm Type

Active Comparator

Arm Description

Colloid group receive colloid preferentially for intravenous volume expansion, until 30 ml/kg. The same transfusion protocol is applied in both groups.

Intervention Type

Drug

Intervention Name(s)

Crystalloid

Other Intervention Name(s)

normal saline

Intervention Description

normal saline administration for volume expansion in hypovolemic status

Intervention Type

Drug

Intervention Name(s)

Colloid

Other Intervention Name(s)

HES 130/0.4

Intervention Description

HES 130/0.4 administration for volume expansion in hypovolemic status

Primary Outcome Measure Information:

Title

Acute Kidney Injury

Time Frame