NCT02950974

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2014

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2014

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

October 27, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 1, 2016

Completed
Last Updated

November 1, 2016

Status Verified

October 1, 2016

Enrollment Period

4 months

First QC Date

October 27, 2016

Last Update Submit

October 28, 2016

Conditions

Change in Serum Chloride Level

Keywords

sterofundinresuscitationnormal salinechloridefluidSIDpHosmolalityurine

Outcome Measures

Primary Outcomes (1)

  • Change in serum chloride

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

    4 hours

Secondary Outcomes (5)

  • Change in serum pH

    4 hours

  • Change in serum osmolality

    4 hours

  • Change in serum SID

    4 hours

  • Time to first void

    Within 24 hours

  • Urine volume

    Within 24 hours

Study Arms (2)

NSS

ACTIVE COMPARATOR

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

Drug: SterofundinDrug: NSS

Sterofundin

EXPERIMENTAL

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

Drug: SterofundinDrug: NSS

Interventions

SterofundinDRUG

Fluid loading

NSSSterofundin
NSSDRUG

Fluid loading

NSSSterofundin

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • No underlying disease
  • LVEF \> 0.5
  • No current medication usage

You may not qualify if:

  • Pregnancy or lactation
  • BMI \<18 or \>25
  • Fever presented in the past 2 weeks

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • 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.

    PMID: 18313809BACKGROUND

  • Chowdhury 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.

    PMID: 22580944BACKGROUND

  • Yunos 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.

    PMID: 23073953BACKGROUND

  • Morgan 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.

    PMID: 14991093BACKGROUND

MeSH Terms

Conditions

Sudden Infant Death

Interventions

sterofundin

Condition Hierarchy (Ancestors)

Death, SuddenDeathPathologic ProcessesPathological Conditions, Signs and SymptomsInfant Death

Study Officials

  • Sunthiti Morakul, MD

    Ramathibodi Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

October 27, 2016

First Posted

November 1, 2016

Study Start

November 1, 2014

Primary Completion

March 1, 2015

Study Completion

March 1, 2015

Last Updated

November 1, 2016

Record last verified: 2016-10

Data Sharing

IPD Sharing
Will not share