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

Not Applicable

Completed

• Conditions: Change in Serum Chloride Level
• Interventions: Drug: Sterofundin; Drug: NSS

• Registration Number: NCT02950974
• Lead Sponsor: Ramathibodi Hospital

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.

Study Timeline

• Study Start: 2014-11
• Primary Completion: 2015-03
• Study Completion: 2015-03
• Status Verified: 2016-10
• Study First Submitted: 2016-10-27
• Study First Submitted QC: 2016-10-28
• Last Update Submitted: 2016-10-28
• Study First Posted: 2016-11-01
• Last Update Posted: 2016-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
NSS	Sterofundin	NSS 30 ml/kg (maximum of 2 litres) intravenous load over 1 hour
NSS	NSS	NSS 30 ml/kg (maximum of 2 litres) intravenous load over 1 hour
Sterofundin	Sterofundin	Sterofundin solution 30 ml/kg (maximum of 2 litres) intravenous load over 1 hour
Sterofundin	NSS	Sterofundin solution 30 ml/kg (maximum of 2 litres) intravenous load over 1 hour

Primary Outcome Measures

Name	Time	Method
Change in serum chloride	4 hours	At 0, 1, 2, and 4 hours from initiation

Secondary Outcome Measures

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