Fluid Kinetics in Patients With Diabetic Ketoacidosis

NCT ID: NCT02172092

Last Updated: 2019-12-12

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

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-08-31

Study Completion Date

2019-02-28

Brief Summary

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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.

Detailed Description

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Patients treated for diabetic ketoacidosis receive 1000 ml of Sodium Chloride during the first 30 minutes of treatment.

Before, during and after this infusion regular blood samples(and urine) are collected (0, 10, 20, 30, 35, 40, 45, 50, 60, 120, 180 and 300 minutes after infusion start).

B-Hemoglobin, P-Albumine, B-Glucose, P-Sodium, P-Potassium. P-Chlorides, U-Sodium, U-Chloride and U-Glucose. Hourly volume of urine is measured.

The 30 minute infusion can be used to calculate the urine extracellular volume. Thereafter during infusion of Ringers acetate changes in electrolytes in blood as well as urine volume and in the urine excreted electrolytes can be used to calculate the fluid shifts between the different fluid compartments.

Eventually 8 to 12 hours later a second infusion of SodiumChloride is as a control performed.

Conditions

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Diabetes

Keywords

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Diabetes Ketoacidosis fluid shift

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Ketoacidosis

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

Group Type EXPERIMENTAL

SodiumChloride

Intervention Type DRUG

Infusion of SodiumChloride, blood samples to calculate extracellular volume.

Interventions

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SodiumChloride

Infusion of SodiumChloride, blood samples to calculate extracellular volume.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* unconscious patient
Minimum Eligible Age

17 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Vrinnevi Hospital

OTHER

Sponsor Role collaborator

University Hospital, Linkoeping

OTHER

Sponsor Role lead

Responsible Party

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Joachim Zdolsek

MD, Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Robert Hahn, Prof

Role: STUDY_DIRECTOR

Linkoeping University

Locations

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Vrinnevi Hospital

Norrköping, Östergötland County, Sweden

Site Status

Countries

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Sweden

References

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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.

Reference Type DERIVED
PMID: 36038699 (View on PubMed)

Other Identifiers

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FDKA

Identifier Type: -

Identifier Source: org_study_id