Fluid Kinetics in Patients With Diabetic Ketoacidosis

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02172092

Acronym

FDKA

Enrollment

Registered

2014-06-24

Start date

2014-08-31

Completion date

2019-02-28

Last updated

2019-12-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes

Keywords

Diabetes, Ketoacidosis, fluid shift

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.

Detailed description

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.

Interventions

DRUGSodiumChloride

Infusion of SodiumChloride, blood samples to calculate extracellular volume.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

17 Years to 80 Years

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

* unconscious patient

Design outcomes

Primary

Measure	Time frame	Description
Extracellular volume	120 minutes	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.

Secondary

Measure	Time frame	Description
Distribution of strong and weak acids	12 hours	Blood gases are followed. With the Stuart/(Loob) concept it is determined to what degree ketones, lactate or electrolyte shifts influence the acidosis of the blood.

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 11, 2026