Fluid Kinetics in Patients With Diabetic Ketoacidosis

Diabetes Clinical Trial

— FDKA  

Official title:

Fluid Kinetics in Patients With Diabetic Ketoacidosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02172092
• Other study ID #: FDKA
• Status: Completed
• Phase: N/A
• Start date: August 2014
• Est. completion date: February 2019

Study information

• Verified date: December 2019
• Source: University Hospital, Linkoeping
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: February 2019
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 17 Years to 80 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• unconscious patient

Related Conditions & MeSH terms

• Diabetes
• Diabetic Ketoacidosis
• Ketosis

Intervention

Drug:
• SodiumChloride
Infusion of SodiumChloride, blood samples to calculate extracellular volume.

Locations

Country	Name	City	State
Sweden	Vrinnevi Hospital	Norrköping	Östergötland

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Linkoeping	Vrinnevi Hospital

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Distribution of strong and weak acids	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.	12 hours