Change in Serum Chloride LevelNCT02950974
Change in Serum Chloride Level After Loading Dose of Sterofundin Solution Compared With Normal Saline Solution
A study testing Sterofundin and NSS in people with Change in Serum Chloride Level, run by Ramathibodi Hospital.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Change in Serum Chloride Level
- What is being tested?
- Sterofundin and NSS
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Nov 2014to Mar 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- No underlying disease
- LVEF > 0.5
- No current medication usage
Who cannot join
- Pregnancy or lactation
- BMI <18 or >25
- Fever presented in the past 2 weeks
About this study
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.
Read the 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.
- Conditions
- Change in Serum Chloride Level
- Being tested
- Sterofundin, NSS
- Keywords
- sterofundin, resuscitation, normal saline, chloride, fluid, SID, pH, osmolality, urine
- Medical subject headings
- Sudden Infant Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SterofundinDrug
Fluid loading
NSSDrug
Fluid loading
| Study group | Role | What they receive |
|---|---|---|
| NSS | Active comparator | NSS 30 ml/kg (maximum of 2 litres) intravenous load over 1 hour Receives: Drug: Sterofundin; Drug: NSS |
| Sterofundin | Experimental | Sterofundin solution 30 ml/kg (maximum of 2 litres) intravenous load over 1 hour Receives: Drug: Sterofundin; Drug: NSS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in serum chloride
At 0, 1, 2, and 4 hours from initiation
Measured: 4 hours
Secondary outcomes (5)
Change in serum pH
At 0, 1, 2, and 4 hours from initiation
Measured: 4 hours
Change in serum osmolality
At 0, 1, 2, and 4 hours from initiation
Measured: 4 hours
Change in serum SID
At 0, 1, 2, and 4 hours from initiation
Measured: 4 hours
Time to first void
Time in minutes from initiation of fluid to first urination
Measured: Within 24 hours
Urine volume
Volume of first urination in ml
Measured: Within 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2016 (estimated)
- Study startNov 2014
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Change in Serum Chloride LevelStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ramathibodi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cherdkiat karnjanarachata, Ramathibodi Hospital
- Investigators
- Sunthiti Morakul, MD, Principal investigator, Ramathibodi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02950974
- Sponsor's protocol ID
- Stero
- Status last verified
- Oct 2016
- First submitted
- 27 Oct 2016
- Last updated
- 1 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
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.
PubMed 18313809Chowdhury 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.
PubMed 22580944Yunos 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.
PubMed 23073953Morgan 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.
PubMed 14991093
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Change in Serum Chloride Level After Loading Dose of Sterofundin Solution Compared With Normal Saline Solution
- ClinicalTrials.gov ID
- NCT02950974
- Acronym / sponsor ID
- Stero
- Conditions
- Change in Serum Chloride Level
- Keywords
- sterofundin, resuscitation, normal saline, chloride, fluid, SID, pH, osmolality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Ramathibodi HospitalUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 1 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NSS | Active comparator | Drug: Sterofundin, Drug: NSSNSS 30 ml/kg (maximum of 2 litres) intravenous load over 1 hour |
| Sterofundin | Experimental | Drug: Sterofundin, Drug: NSSSterofundin solution 30 ml/kg (maximum of 2 litres) intravenous load over 1 hour |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- No underlying disease
- LVEF > 0.5
- No current medication usage
Key exclusion criteria (3 listed)
- Pregnancy or lactation
- BMI <18 or >25
- Fever presented in the past 2 weeks
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SterofundinFluid loading | Drug | NSS, Sterofundin |
| NSSFluid loading | Drug | NSS, Sterofundin |
Primary outcome
Change in serum chloride
Time frame: 4 hours
At 0, 1, 2, and 4 hours from initiation
5 secondary outcomes
Change in serum pH
Time frame: 4 hours
Change in serum osmolality
Time frame: 4 hours
Change in serum SID
Time frame: 4 hours
Time to first void
Time frame: Within 24 hours
Urine volume
Time frame: Within 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2016.
- Background: PubMed 18313809Awad 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.
- Background: PubMed 22580944Chowdhury 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.
- Background: PubMed 23073953Yunos 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.
- Background: PubMed 14991093Morgan 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sunthiti Morakul, MD principal investigator
Ramathibodi Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Sterofundin and NSS in people with Change in Serum Chloride Level, run by Ramathibodi Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in serum chloride (time frame: 4 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02950974, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2016.