Normal Saline Versus Balance Salt Solution Resuscitation on Kidney Function

March 31, 2016 updated by: Mahidol University

Effect of Normal Saline Versus Balance Salt Solution Resuscitation on Kidney Function; A Randomized Open Label Controlled Study

The purpose of this study is to determine Acute kidney injury incidence between sterofundin and normal saline ; Resuscitation shock patients

Study Overview

Status

Unknown

Detailed Description

Sample size:Compare proportion for independent two groups formula. n=sample size α risk of 0.05, Statistical power of 80% P1 =incidence of acute kidney injury (AKI) in control (0.6)* P2 =incidence of acute kidney injury (AKI) in balanced salt solution (0.4)** from Ratanarat R,Hantaweepant C,Tangkawattanakul N,et al.The clinical outcome of acute kidney injury in critically ill Thai patients stratified with RIFLE classification.J Med Assoc Thai 2009 Mar;92 Suppl 2:61-7.

α risk of 0.05, Statistical power of 80%

Sample size for interim analysis 1.11 x 97 = 107.67 total 108 (at least 50 cases each arm)

Study Type

Interventional

Enrollment (Anticipated)

107

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 Contact

Study Locations

      • Bangkok, Thailand, 10700
        • Recruiting
        • Mahidol University
        • Contact:

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Shock patients (hypotension with signs of poor tissue perfusion)

Exclusion Criteria:

  • Age < 18 yr
  • Cardiogenic shock patients (History of ST elevation and Left ventricular ejection fraction (LVEF) < 35%),
  • Prolong shock >24 hrs,
  • Received chloride rich crystalloid (0.9% saline) or chloride rich colloid > 1000 ml within 72 hrs before recruitment
  • Do-not-resuscitation patients,
  • Contraindication for IV fluid administration such as pulmonary edema.,
  • Stage V chronic kidney disease (CKD),
  • chronic Hemodialysis or Peritonealdialyse

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: normal saline
normal saline for fluid resuscitation and maintenance for 72 hours
Normal saline for shock patients in the first 72 hours
Experimental: sterofundin
sterofundin for fluid resuscitation and maintenance for 72 hours
sterofundin for shock patients in the first 72 hours
Other Names:
  • balance salt solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
acute kidney injury
Time Frame: 7 day
Number of Participants with acute kidney injury divided by KIDNEY DISEASE | IMPROVING GLOBAL OUTCOMES (KDIGO) Staging
7 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Requirement of Renal replacement therapy (RRT)
Time Frame: up to 7 day
up to 7 day
sodium level
Time Frame: day 1-3
change from baseline
day 1-3
potassium level
Time Frame: day 1-3
change from baseline
day 1-3
chloride level
Time Frame: day 1-3
change from baseline
day 1-3
bicarbonate level
Time Frame: day 1-3
change from baseline
day 1-3
28-day mortality
Time Frame: 28 days after admission
Number of Participants death within 28 day after admission
28 days after admission
ICU mortality
Time Frame: ICU admission up to 28 day
Number of Participants death at ICU within 28 day after admission
ICU admission up to 28 day
hospital stay
Time Frame: during hospital admission up to 28 day
number of Hospital admission date
during hospital admission up to 28 day
ICU hospital stay
Time Frame: during admission up to 28 day
number of Hospital admission date
during admission up to 28 day
mean arterial pressure
Time Frame: day1-3
mmHg (average)
day1-3
dose of norepinephrine
Time Frame: day1-3
(µg/k/min)
day1-3
dose of adrenaline
Time Frame: day1-3
(µg/k/min)
day1-3

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Ranistha Ratanarat, MD, Mahidol University

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, 2014

Primary Completion (Anticipated)

June 1, 2017

Study Completion (Anticipated)

October 1, 2017

Study Registration Dates

First Submitted

July 29, 2015

First Submitted That Met QC Criteria

August 9, 2015

First Posted (Estimate)

August 13, 2015

Study Record Updates

Last Update Posted (Estimate)

April 4, 2016

Last Update Submitted That Met QC Criteria

March 31, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • Si566/2014

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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