Change in Serum Chloride Level After Loading Dose of Sterofundin Solution Compared With Normal Saline Solution

October 28, 2016 updated by: Cherdkiat karnjanarachata, Ramathibodi Hospital
Prospective, crossover, randomized trial to evaluate plasma compositions after loading dose of sterofundin solution given to healthy volunteer in the resuscitation manner compared with normal saline solution.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

10 healthy volunteers were randomly assigned to receive either normal saline or sterofundin for the first solution in dose of 30 mL/kg (max 2 L) over 1 hour. Blood was collected at baseline (T0), at 60 minutes (T1), 120 minutes (T2), and 240 minutes (T4) from baseline. Time to fist void after initiation of fluid and urine volume were also recorded. After wash-out period of at least 1 week, crossover studies were performed with another fluid.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

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

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • No underlying disease
  • LVEF > 0.5
  • No current medication usage

Exclusion Criteria:

  • Pregnancy or lactation
  • BMI <18 or >25
  • Fever presented in the past 2 weeks

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: CROSSOVER
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: NSS
NSS 30 ml/kg (maximum of 2 litres) intravenous load over 1 hour
Drug: Sterofundin
Fluid loading
Drug: NSS
Fluid loading
EXPERIMENTAL: Sterofundin
Sterofundin solution 30 ml/kg (maximum of 2 litres) intravenous load over 1 hour
Drug: Sterofundin
Fluid loading
Drug: NSS
Fluid loading

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in serum chloride
Time Frame: 4 hours
At 0, 1, 2, and 4 hours from initiation
4 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in serum pH
Time Frame: 4 hours
At 0, 1, 2, and 4 hours from initiation
4 hours
Change in serum osmolality
Time Frame: 4 hours
At 0, 1, 2, and 4 hours from initiation
4 hours
Change in serum SID
Time Frame: 4 hours
At 0, 1, 2, and 4 hours from initiation
4 hours
Time to first void
Time Frame: Within 24 hours
Time in minutes from initiation of fluid to first urination
Within 24 hours
Urine volume
Time Frame: Within 24 hours
Volume of first urination in ml
Within 24 hours

Collaborators and Investigators

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

Sponsor

Ramathibodi Hospital

Investigators

  • Principal Investigator: Sunthiti Morakul, MD, Ramathibodi 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, 2014

Primary Completion (ACTUAL)

March 1, 2015

Study Completion (ACTUAL)

March 1, 2015

Study Registration Dates

First Submitted

October 27, 2016

First Submitted That Met QC Criteria

October 28, 2016

First Posted (ESTIMATE)

November 1, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

November 1, 2016

Last Update Submitted That Met QC Criteria

October 28, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Stero

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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