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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02950974
Enrollment
20
Registered
2016-11-01
Start date
2014-11-30
Completion date
2015-03-31
Last updated
2016-11-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Change in Serum Chloride Level

Keywords

sterofundin, resuscitation, normal saline, chloride, fluid, SID, pH, osmolality, urine

Brief 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.

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.

Interventions

Fluid loading

DRUGNSS

Fluid loading

Sponsors

Ramathibodi Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Change in serum chloride4 hoursAt 0, 1, 2, and 4 hours from initiation

Secondary

MeasureTime frameDescription
Change in serum pH4 hoursAt 0, 1, 2, and 4 hours from initiation
Change in serum osmolality4 hoursAt 0, 1, 2, and 4 hours from initiation
Change in serum SID4 hoursAt 0, 1, 2, and 4 hours from initiation
Time to first voidWithin 24 hoursTime in minutes from initiation of fluid to first urination
Urine volumeWithin 24 hoursVolume of first urination in ml

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026