DiabetesFDKANCT02172092
Fluid Kinetics in Patients With Diabetic Ketoacidosis
A study testing SodiumChloride in people with Diabetes, run by University Hospital, Linkoeping at 1 site in Sweden.
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… Read more about this study
- Who is it for?
- Ages 17 to 80 years
- Conditions the study is for
- Diabetes
- What is being tested?
- SodiumChloride
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteSweden
- Study dates
- Aug 2014to Feb 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- diabetic ketoacidosis needing icu care, conscious patient, signed informed consent.
Who cannot join
- unconscious patient
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Diabetes
- Being tested
- SodiumChloride
- Keywords
- Diabetes, Ketoacidosis, fluid shift
- Medical subject headings
- Diabetes Mellitus, Ketosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SodiumChlorideDrug
Infusion of SodiumChloride, blood samples to calculate extracellular volume.
| Study group | Role | What they receive |
|---|---|---|
| Ketoacidosis | Experimental | Patients treated for diabetic ketoacidosis at the Intensive care unit, Vrinnevi Hospital, Norrköping. Receives: Drug: SodiumChloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 120 minutes
Secondary outcomes (1)
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.
Measured: 12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2014 (estimated)
- Study startAug 2014
- Primary completionDec 2018
- Study completionFeb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Linkoeping
- Sponsor type
- University, hospital or other
- Collaborators
- Vrinnevi Hospital
- Responsible party
- Principal investigator, Joachim Zdolsek, University Hospital, Linkoeping
- Investigators
- Robert Hahn, Prof, Study director, Linkoeping University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02172092
- Sponsor's protocol ID
- FDKA
- Acronym
- FDKA
- Status last verified
- Dec 2019
- First submitted
- 22 Jun 2014
- Last updated
- 12 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 36038699
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fluid Kinetics in Patients With Diabetic Ketoacidosis
- ClinicalTrials.gov ID
- NCT02172092
- Acronym / sponsor ID
- FDKA / FDKA
- Conditions
- Diabetes
- Keywords
- Diabetes, Ketoacidosis, fluid shift
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- University Hospital, LinkoepingUniversity, hospital or other
- Collaborators
- Vrinnevi Hospital
- Study start
- Aug 2014
- Primary completion
- Dec 2018 (actual)
- Study completion
- Feb 2019 (actual)
- First posted
- 24 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ketoacidosis | Experimental | Drug: SodiumChloridePatients treated for diabetic ketoacidosis at the Intensive care unit, Vrinnevi Hospital, Norrköping. |
Who may qualify
- Ages
- 17 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- diabetic ketoacidosis needing icu care, conscious patient, signed informed consent.
Key exclusion criteria (1 listed)
- unconscious patient
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SodiumChlorideInfusion of SodiumChloride, blood samples to calculate extracellular volume. | Drug | Ketoacidosis |
Primary outcome
Extracellular volume
Time frame: 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.
1 secondary outcome
Distribution of strong and weak acids
Time frame: 12 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2019.
- Derived from this study: PubMed 36038699Svensson 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Hahn, Prof study director
Linkoeping University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SodiumChloride in people with Diabetes, run by University Hospital, Linkoeping at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Extracellular volume (time frame: 120 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02172092, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2019.