NCT01360333

Brief Summary

When subjected to fluid loss or fluid deficiency irrespective of disease or environmental factors it is discussed how to rehydrate or how to hydrate prophylactic. In medical care it is common to give infusions. However it has increasingly become common to hydrate the patient through the mouth even early after bowel surgery. Moreover it is more simple to provide energy the natural way. Which fluid to give, depends on several factors such as possibility to drink, the volume and emptying of the stomach as well as the fluid absorption in the bowel. The provided fluid can also influence this process depending on temperature, osmolality/tonicity and composition (carbohydrates or salts). In this study we wish to study the speed with which the provided fluid is absorbed by the bowels and how fast the fluid is distributed to the different body compartments depending on it's composition. The three fluids will be either tap water, high sodium chloride and a carbohydrate rich fluid.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2011

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2011

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

May 23, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 25, 2011

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

May 14, 2012

Status Verified

May 1, 2012

Enrollment Period

5 months

First QC Date

May 23, 2011

Last Update Submit

May 11, 2012

Conditions

Keywords

DehydrationHydration

Outcome Measures

Primary Outcomes (1)

  • change in hydration

    volume kinetics: calculation from hemoglobin variations

    2.5 hours

Secondary Outcomes (1)

  • fluid kinetic effects of oral carbohydrates

    2.5 hours

Study Arms (1)

Tap water, sodium chloride, carbohydrate rich fluid

OTHER
Other: tap water, sodium chloride, carbohydrate rich fluid

Interventions

Ingestion of three different fluids at three different occasions separated by at least one week, A, Tap water. B. Sodium Chloride. C. Carbohydrate rich fluid.

Tap water, sodium chloride, carbohydrate rich fluid

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • healthy volunteer
  • to 50 years old

You may not qualify if:

  • medication
  • any chronical disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Intensive Care Unit, University Hospital

Linköping, Sweden

Location

Related Publications (2)

  • Hahn RG, Wuethrich PY, Zdolsek JH. Can perioperative hemodilution be monitored with non-invasive measurement of blood hemoglobin? BMC Anesthesiol. 2021 May 6;21(1):138. doi: 10.1186/s12871-021-01351-4.

  • Zdolsek J, Metander A, Hahn R. Volume kinetic evaluation of fluid turnover after oral intake of tap water, lemonade and saline in volunteers. BMC Sports Sci Med Rehabil. 2016 Jul 28;8:22. doi: 10.1186/s13102-016-0045-x. eCollection 2016.

MeSH Terms

Conditions

Dehydration

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Water-Electrolyte ImbalanceMetabolic DiseasesNutritional and Metabolic DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Joachim Zdolsek, MD, PhD

    University Hospital, Linköping, Sweden

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

May 23, 2011

First Posted

May 25, 2011

Study Start

May 1, 2011

Primary Completion

October 1, 2011

Study Completion

December 1, 2011

Last Updated

May 14, 2012

Record last verified: 2012-05

Locations