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

NCT ID: NCT02950974

Last Updated: 2016-11-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-11-30

Study Completion Date

2015-03-31

Brief Summary

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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

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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.

Conditions

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Change in Serum Chloride Level

Keywords

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sterofundin resuscitation normal saline chloride fluid SID pH osmolality urine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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NSS

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

Group Type ACTIVE_COMPARATOR

Sterofundin

Intervention Type DRUG

Fluid loading

NSS

Intervention Type DRUG

Fluid loading

Sterofundin

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

Group Type EXPERIMENTAL

Sterofundin

Intervention Type DRUG

Fluid loading

NSS

Intervention Type DRUG

Fluid loading

Interventions

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Sterofundin

Fluid loading

Intervention Type DRUG

NSS

Fluid loading

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ramathibodi Hospital

OTHER

Sponsor Role lead

Responsible Party

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Cherdkiat karnjanarachata

Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sunthiti Morakul, MD

Role: PRINCIPAL_INVESTIGATOR

Ramathibodi Hospital

References

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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.

Reference Type BACKGROUND
PMID: 18313809 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22580944 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23073953 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 14991093 (View on PubMed)

Other Identifiers

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Stero

Identifier Type: -

Identifier Source: org_study_id