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Completed

NCT Number: NCT02950974

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

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.

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Key information

Conditions

Change in Serum Chloride Level Death Death, Sudden Infant Death Pathologic Processes Pathological Conditions, Signs and Symptoms Sudden Infant Death

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sterofundin

Drug

Fluid loading

NSS

Drug

Fluid loading

Primary outcomes

  1. Change in serum chloride

    Time frame: 4 hours

    At 0, 1, 2, and 4 hours from initiation

Secondary outcomes

  1. Change in serum pH

    Time frame: 4 hours

    At 0, 1, 2, and 4 hours from initiation

  2. Change in serum osmolality

    Time frame: 4 hours

    At 0, 1, 2, and 4 hours from initiation

  3. Change in serum SID

    Time frame: 4 hours

    At 0, 1, 2, and 4 hours from initiation

  4. Time to first void

    Time frame: Within 24 hours

    Time in minutes from initiation of fluid to first urination

  5. Urine volume

    Time frame: Within 24 hours

    Volume of first urination in ml

Sponsors and collaborators

Lead sponsor

Ramathibodi Hospital

Other

Registry information

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Nov 1, 2016
Registry last updated
Nov 1, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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