Fluid Kinetics in Patients With Diabetic Ketoacidosis

Not Applicable

Completed

• Conditions: Diabetes
• Interventions: Drug: SodiumChloride

• Registration Number: NCT02172092
• Lead Sponsor: University Hospital, Linkoeping

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.

Study Timeline

• Study First Submitted: 2014-06-22
• Study First Submitted QC: 2014-06-23
• Study First Posted: 2014-06-24
• Study Start: 2014-08
• Primary Completion: 2018-12
• Study Completion: 2019-02
• Status Verified: 2019-12
• Last Update Submitted: 2019-12-09
• Last Update Posted: 2019-12-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

Inclusion Criteria

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

Exclusion Criteria

• unconscious patient

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ketoacidosis	SodiumChloride	Patients treated for diabetic ketoacidosis at the Intensive care unit, Vrinnevi Hospital, Norrköping.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Vrinnevi Hospital; 🇸🇪 Norrköping, Östergötland, Sweden