NCT02172092

Brief Summary

The purpose with the study is to follow the fluid shifts that occur during fluid resuscitation of patients with diabetic ketoacidosis. In the study measurements of changes in blood and urine concentrations of Sodium and Chloride as well as blood hemoglobin are used to mathematically calculate changes in distribution volumes of these different endogenous markers.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
17

participants targeted

Target at below P25 for not_applicable diabetes

Timeline
Completed

Started Aug 2014

Longer than P75 for not_applicable diabetes

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

First Submitted

Initial submission to the registry

June 22, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 24, 2014

Completed
1 month until next milestone

Study Start

First participant enrolled

August 1, 2014

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2019

Completed
Last Updated

December 12, 2019

Status Verified

December 1, 2019

Enrollment Period

4.3 years

First QC Date

June 22, 2014

Last Update Submit

December 9, 2019

Conditions

Diabetes

Keywords

DiabetesKetoacidosisfluid shift

Outcome Measures

Primary Outcomes (1)

  • Extracellular volume

    Masse balance as well as dilution af Sodium and Chloride are used to calculate extracellular volume during an infusion of SodiumChloride. Urine Sodium and Chloride are also measured to register and correct the mass balance.

    120 minutes

Secondary Outcomes (1)

  • Distribution of strong and weak acids

    12 hours

Study Arms (1)

Ketoacidosis

EXPERIMENTAL

Patients treated for diabetic ketoacidosis at the Intensive care unit, Vrinnevi Hospital, Norrköping.

Drug: SodiumChloride

Interventions

SodiumChlorideDRUG

Infusion of SodiumChloride, blood samples to calculate extracellular volume.

Ketoacidosis

Eligibility Criteria

Age17 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • diabetic ketoacidosis needing icu care, conscious patient, signed informed consent.

You may not qualify if:

  • unconscious patient

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vrinnevi Hospital

Norrköping, Östergötland County, 60379, Sweden

Location

Related Publications (1)

  • Svensson R, Hahn RG, Zdolsek JH, Bahlmann H. Plasma volume expansion reveals hidden metabolic acidosis in patients with diabetic ketoacidosis. Intensive Care Med Exp. 2022 Dec;10(1):36. doi: 10.1186/s40635-022-00464-5. Epub 2022 Aug 29.

    PMID: 36038699DERIVED

MeSH Terms

Conditions

Diabetes MellitusKetosis

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAcidosisAcid-Base Imbalance

Study Officials

  • Robert Hahn, Prof

    Linkoeping University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, Associate Professor

Study Record Dates

First Submitted

June 22, 2014

First Posted

June 24, 2014

Study Start

August 1, 2014

Primary Completion

December 1, 2018

Study Completion

February 1, 2019

Last Updated

December 12, 2019

Record last verified: 2019-12

Locations

SE(1)