Fluid Kinetics in Patients With Diabetic Ketoacidosis (FDKA)
Primary Purpose
Diabetes
Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
SodiumChloride
Sponsored by
About this trial
This is an interventional other trial for Diabetes focused on measuring Diabetes, Ketoacidosis, fluid shift
Eligibility Criteria
Inclusion Criteria:
- diabetic ketoacidosis needing icu care, conscious patient, signed informed consent.
Exclusion Criteria:
- unconscious patient
Sites / Locations
- Vrinnevi Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Ketoacidosis
Arm Description
Patients treated for diabetic ketoacidosis at the Intensive care unit, Vrinnevi Hospital, Norrköping.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT02172092
First Posted
June 22, 2014
Last Updated
December 9, 2019
Sponsor
University Hospital, Linkoeping
Collaborators
Vrinnevi Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02172092
Brief Title
Fluid Kinetics in Patients With Diabetic Ketoacidosis
Acronym
FDKA
Official Title
Fluid Kinetics in Patients With Diabetic Ketoacidosis
Study Type
Interventional
2. Study Status
Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
August 2014 (undefined)
Primary Completion Date
December 2018 (Actual)
Study Completion Date
February 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital, Linkoeping
Collaborators
Vrinnevi Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes
Keywords
Diabetes, Ketoacidosis, fluid shift
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
17 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ketoacidosis
Arm Type
Experimental
Arm Description
Patients treated for diabetic ketoacidosis at the Intensive care unit, Vrinnevi Hospital, Norrköping.
Intervention Type
Drug
Intervention Name(s)
SodiumChloride
Intervention Description
Infusion of SodiumChloride, blood samples to calculate extracellular volume.
Primary Outcome Measure Information:
Title
Extracellular volume
Description
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.
Time Frame
120 minutes
Secondary Outcome Measure Information:
Title
Distribution of strong and weak acids
Description
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.
Time Frame
12 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
17 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
diabetic ketoacidosis needing icu care, conscious patient, signed informed consent.
Exclusion Criteria:
unconscious patient
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Hahn, Prof
Organizational Affiliation
Linkoeping University
Official's Role
Study Director
Facility Information:
Facility Name
Vrinnevi Hospital
City
Norrköping
State/Province
Östergötland
ZIP/Postal Code
60379
Country
Sweden
12. IPD Sharing Statement
Citations:
PubMed Identifier
36038699
Citation
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.
Results Reference
derived
Learn more about this trial
Fluid Kinetics in Patients With Diabetic Ketoacidosis
We'll reach out to this number within 24 hrs