- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02950974
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
|
Fluid loading
Fluid loading
|
EXPERIMENTAL: Sterofundin
Sterofundin solution 30 ml/kg (maximum of 2 litres) intravenous load over 1 hour
|
Fluid loading
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
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
- Awad S, Allison SP, Lobo DN. The history of 0.9% saline. Clin Nutr. 2008 Apr;27(2):179-88. doi: 10.1016/j.clnu.2008.01.008. Epub 2008 Mar 3.
- Chowdhury AH, Cox EF, Francis ST, Lobo DN. A randomized, controlled, double-blind crossover study on the effects of 2-L infusions of 0.9% saline and plasma-lyte(R) 148 on renal blood flow velocity and renal cortical tissue perfusion in healthy volunteers. Ann Surg. 2012 Jul;256(1):18-24. doi: 10.1097/SLA.0b013e318256be72. Erratum In: Ann Surg. 2013 Dec;258(6):1118.
- Yunos NM, Bellomo R, Hegarty C, Story D, Ho L, Bailey M. Association between a chloride-liberal vs chloride-restrictive intravenous fluid administration strategy and kidney injury in critically ill adults. JAMA. 2012 Oct 17;308(15):1566-72. doi: 10.1001/jama.2012.13356.
- Morgan TJ, Venkatesh B, Hall J. Crystalloid strong ion difference determines metabolic acid-base change during acute normovolaemic haemodilution. Intensive Care Med. 2004 Jul;30(7):1432-7. doi: 10.1007/s00134-004-2176-x. Epub 2004 Feb 28.
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
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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