Treatment Diabetic Ketoacidosis, Electrolyte Balance EffectsNCT06399510
Electrolyte Balance Effects of Sterofundin Versus Normal Saline in Diabetic Ketoacidosis
A study testing Sterofundin fluid therapy in people with Treatment Diabetic Ketoacidosis, Electrolyte Balance Effects, run by Universiti Sains Malaysia at 1 site in Malaysia.
Trial summary
The goal of this prospective single centered randomized control trial is to compare the electrolyte balance effects between Sterofundin and Normal Saline in Diabetic Ketoacidosis patients. The main questions it aims to answer are: i. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Treatment Diabetic Ketoacidosis, Electrolyte Balance Effects
- What is being tested?
- Sterofundin fluid therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteMalaysia
- Study dates
- 1 Mar 2024to 30 Apr 2025
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- DKA.
- Aged ≥ 18 years old.
- Patients admitted to ICU < 12 hours after initial fluid resuscitation from emergency department/ ward.
Who cannot join
- End stage renal failure
- Heart failure
- Started treatment of sodium bicarbonate infusion prior to ICU admission
- Known allergy to Sterofundin
Trial locations and contacts
1 site in 1 country.
Malaysia1 site, 1 recruiting
- Recruiting
Hospital Universiti Sains Malaysia
Kubang Kerian, Kelantan, 16150
MOHD ZULFAKAR BIN MAZLAN, Master, +6097673000 ext. 6104, zulfakar@usm.my
JIE SHI HOW, MD
About this study
The goal of this prospective single centered randomized control trial is to compare the electrolyte balance effects between Sterofundin and Normal Saline in Diabetic Ketoacidosis patients. The main questions it aims to answer are:
- Is there any difference in duration of bicarbonate (HCO3-) to reach equal or more than 15mmol/L from the initial blood taking in between Sterofundin and NS fluid use in DKA patients? ii. Is there any difference in the level of post-infusion serum sodium (Na+) between Sterofundin and NS fluid use in DKA patients? iii. Is there any difference in the level of post-infusion serum potassium (K+) between Sterofundin and NS fluid use in DKA patients?
Patients will be randomized in a 1:1 ratio to receive IV Sterofundin (intervention) or IV Normal Saline (standard care). The patient will have the respective fluid regime as the main fluid therapy during the first 24 hours of ICU stay. If patients were randomized to the control arm, the fluid regime for the first 24 hours in ICU will be normal saline. If patients were randomized to the interventional arm, the main fluid therapy during the first 24 hours of ICU stay will be Sterofundin.
- Being tested
- Sterofundin fluid therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sterofundin fluid therapyOther
Sterofundin is known as balanced solution which has similar electrolytes content as per human plasma.
| Study group | Role | What they receive |
|---|---|---|
| Normal Saline | Active comparator | If patients were randomized to the control arm, the fluid regime for the first 24 hours in ICU will be normal saline. Receives: Other: Sterofundin fluid therapy |
| Sterofundin | Experimental | If patients were randomized to the interventional arm, the main fluid therapy during the first 24 hours of ICU stay will be Sterofundin. Receives: Other: Sterofundin fluid therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The duration taken for serum HCO3 ≥ 15 within 24 hours ICU admission.
Measured: 24 Hours
Mean difference of serum sodium level between Sterofundin and normal saline fluid use in diabetic ketoacidosis patients
Measured: 24 Hours
Mean difference of serum potassium level between Sterofundin and normal saline fluid use in diabetic ketoacidosis patients.
Measured: 24 Hours
Secondary outcomes (2)
The Need of Renal Replacement Therapy
Measured: 30 days
Mechanical ventilation day
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2024
- Study start1 Mar 2024
- Primary completion31 Mar 2025 (estimated)
- Study completion30 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Treatment Diabetic Ketoacidosis, Electrolyte Balance EffectsStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universiti Sains Malaysia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohd Zulfakar Mazlan, MBBS, Universiti Sains Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06399510
- Sponsor's protocol ID
- USM/JEPeM/KK/23100751
- Status last verified
- Apr 2024
- First submitted
- 30 Apr 2024
- Last updated
- 3 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electrolyte Balance Effects of Sterofundin Versus Normal Saline in Diabetic Ketoacidosis
- ClinicalTrials.gov ID
- NCT06399510
- Acronym / sponsor ID
- USM/JEPeM/KK/23100751
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- Universiti Sains MalaysiaUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 31 Mar 2025 (estimated)
- Study completion
- 30 Apr 2025 (estimated)
- First posted
- 3 May 2024 (actual)
- 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 goal of this prospective single centered randomized control trial is to compare the electrolyte balance effects between Sterofundin and Normal Saline in Diabetic Ketoacidosis patients. The main questions it aims to answer are:
- Is there any difference in duration of bicarbonate (HCO3-) to reach equal or more than 15mmol/L from the initial blood taking in between Sterofundin and NS fluid use in DKA patients? ii. Is there any difference in the level of post-infusion serum sodium (Na+) between Sterofundin and NS fluid use in DKA patients? iii. Is there any difference in the level of post-infusion serum potassium (K+) between Sterofundin and NS fluid use in DKA patients?
Patients will be randomized in a 1:1 ratio to receive IV Sterofundin (intervention) or IV Normal Saline (standard care). The patient will have the respective fluid regime as the main fluid therapy during the first 24 hours of ICU stay. If patients were randomized to the control arm, the fluid regime for the first 24 hours in ICU will be normal saline. If patients were randomized to the interventional arm, the main fluid therapy during the first 24 hours of ICU stay will be Sterofundin.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normal Saline | Active comparator | Other: Sterofundin fluid therapyIf patients were randomized to the control arm, the fluid regime for the first 24 hours in ICU will be normal saline. |
| Sterofundin | Experimental | Other: Sterofundin fluid therapyIf patients were randomized to the interventional arm, the main fluid therapy during the first 24 hours of ICU stay will be Sterofundin. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- DKA.
- Aged ≥ 18 years old.
- Patients admitted to ICU < 12 hours after initial fluid resuscitation from emergency department/ ward.
Key exclusion criteria (4 listed)
- End stage renal failure
- Heart failure
- Started treatment of sodium bicarbonate infusion prior to ICU admission
- Known allergy to Sterofundin
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 |
|---|---|---|
| Sterofundin fluid therapySterofundin is known as balanced solution which has similar electrolytes content as per human plasma. | Other | Normal Saline, Sterofundin |
Primary outcome
The duration taken for serum HCO3 ≥ 15 within 24 hours ICU admission.
Time frame: 24 Hours
Mean difference of serum sodium level between Sterofundin and normal saline fluid use in diabetic ketoacidosis patients
Time frame: 24 Hours
Mean difference of serum potassium level between Sterofundin and normal saline fluid use in diabetic ketoacidosis patients.
Time frame: 24 Hours
2 secondary outcomes
The Need of Renal Replacement Therapy
Time frame: 30 days
Mechanical ventilation day
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2024.
- Individual participant dataSharing planned: No
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sterofundin fluid therapy in people with Treatment Diabetic Ketoacidosis, Electrolyte Balance Effects, run by Universiti Sains Malaysia at 1 site in Malaysia.
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 3 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 3 May 2024. 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 Malaysia. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shi Jie How (+601151362495, shijie.how@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The duration taken for serum HCO3 ≥ 15 within 24 hours ICU admission. (time frame: 24 Hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 May 2024.