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

Mahidol University

Status: Completed

Conditions: Change in Serum Chloride Level

Treatments: Drug: NSS; Drug: Sterofundin

Study type: Interventional

Funder types: Other

Identifiers

NCT02950974

Stero

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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20 participants in 2 patient groups

NSS

Active Comparator group

Description:

NSS 30 ml/kg (maximum of 2 litres) intravenous load over 1 hour

Treatment:

Drug: NSS

Drug: Sterofundin

Sterofundin

Experimental group

Description:

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

Treatment:

Drug: NSS

Drug: Sterofundin