HyperglycemiaNCT06180824
Efficacy and Safety Between Different Dilution of Insulin
A study testing Gelafundin in people with Hyperglycemia, run by Universiti Sains Malaysia at 1 site in Malaysia.
Trial summary
Hyperglycemia associated with insulin resistance is common in critically ill patients, even in those nondiabetic patients. Hyperglycaemia or relative insulin deficiency (or both) during critical illness may directly or indirectly confer a predisposition to complications, such as severe infections, polyneuropathy… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hyperglycemia
- What is being tested?
- Gelafundin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteMalaysia
- Study dates
- 9 Jan 2024to 31 Dec 2024
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patient admitted to ICU Hospital USM regardless of whether patient intubated or not.
- Adult patient 18 years old and above.
- 2 consecutive blood sugar more than 10 mmol/L including patient with diabetic ketoacidosis and hyperosmolar hyperglycaemic state.
- Within 12 hours from admission.
- Patient not in high inotropic support and with APACHE II score less than 17.
Who cannot join
- Pregnancy.
- History of any allergic from previous gelafundin infusion or known patient to have allergic towards gelafundin (allergic card, or information from relatives)
- Post cardiac arrest or prolonged resuscitation.
- Patient with cardiogenic shock.
Trial locations and contacts
1 site in 1 country.
Malaysia1 site, 1 recruiting
- Recruiting
Mohd Zulfakar Mazlan
Kota Bharu, Kelantan, 16150
Mohd Zulfakar Mazlan, Master, +6097673000 ext. 6104, zulfakar@usm.my
Muhammad Fadhli Rusli, MD
About this study
Official title: A Comparative Study of Efficacy and Safety Between Different Dilution of Insulin Infusion in Controlling Blood Sugar Level in ICU Patient
Hyperglycemia associated with insulin resistance is common in critically ill patients, even in those nondiabetic patients. Hyperglycaemia or relative insulin deficiency (or both) during critical illness may directly or indirectly confer a predisposition to complications, such as severe infections, polyneuropathy, multiple-organ failure, and death. Tight glycaemic control in adult long-stay critically ill patients using intensive insulin therapy reduces absolute mortality. It has been reported that pronounced hyperglycemia may lead to complications in such patients, although data from controlled trials are lacking. However, target glycaemia may be difficult to achieve in clinical practice. Insulin adsorption onto infusion equipment (e.g., infusion tubing) may affect glucose control, possibly leading to hyperglycemia. In the use of low-level intravenous insulin infusion for treating diabetic hyperglycaemia and ketoacidosis adsorption of insulin to containers or plastic infusion apparatus results in significant losses of 60-80% of insulin in dilute physiological saline solution.
Problem statement \& Study rationale
Read more
Up to my knowledge, there is no study that demonstrate differences between types of dilution for insulin infusion in ICU patient in Malaysia; thus, this study is aimed to evaluate it. In 2001 it has been reported that intensive insulin therapy (IIT) in surgical intensive care unit (ICU) patients was associated with reduction in mortality and morbidity as well as other associated factors. There is limited study in comparing dilution of insulin in normal saline and other types of diluents.
Other than that, it is important to know which diluent the best is to choose for the management of hyperglycaemia in ICU patient.
- Conditions
- Hyperglycemia
- Being tested
- Gelafundin
- Keywords
- insulin, hyperglycemia, diluent, plastic syringe
- Medical subject headings
- Hyperglycemia, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GelafundinDrug
Insulin will be diluted with gelafundin colloid fluid in 50mls syringe and tubing (same product manufacturer).
Blood glucose level will be taken from arterial line at presentation or prior to start insulin and checked using glucometer. Then, at 2 hour and 6 hours after initiation of treatment.
| Study group | Role | What they receive |
|---|---|---|
| normal saline | No intervention | Insulin will be diluted with normal saline crystalloid fluid in 50mls syringe and tubing (same product manufacturer). Blood glucose level will be taken from arterial line at presentation or prior to start insulin and checked using glucometer. Then, at 2 hour and 6 hours after initiation of treatment. |
| gelafundin | Active comparator | Insulin will be diluted with gelafundin colloid fluid in 50mls syringe and tubing (same product manufacturer). Blood glucose level will be taken from arterial line at presentation or prior to start insulin and checked using glucometer. Then, at 2 hour and 6 hours after initiation of treatment. Receives: Drug: Gelafundin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood glucose level
Mean of blood glucose level
Measured: At 2 hours
Blood glucose level
Mean of blood glucose level
Measured: At 6 hours
Secondary outcomes (2)
Mortality
Mortality rate
Measured: 14 days
Mortality
Mortality rate
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2023
- Study start9 Jan 2024
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperglycemiaStudies 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
- Model description
- Randomized Control Trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 74 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
- NCT06180824
- Sponsor's protocol ID
- InsulinUSM
- Status last verified
- Apr 2024
- First submitted
- 4 Dec 2023
- Last updated
- 1 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 1 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study of Efficacy and Safety Between Different Dilution of Insulin Infusion in Controlling Blood Sugar Level in ICU Patient
- ClinicalTrials.gov ID
- NCT06180824
- Acronym / sponsor ID
- InsulinUSM
- Conditions
- Hyperglycemia
- Keywords
- insulin, hyperglycemia, diluent, plastic syringe
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 74 participants (estimated)
- Lead sponsor
- Universiti Sains MalaysiaUniversity, hospital or other
- Study start
- 9 Jan 2024 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 26 Dec 2023 (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.
Hyperglycemia associated with insulin resistance is common in critically ill patients, even in those nondiabetic patients. Hyperglycaemia or relative insulin deficiency (or both) during critical illness may directly or indirectly confer a predisposition to complications, such as severe infections, polyneuropathy, multiple-organ failure, and death. Tight glycaemic control in adult long-stay critically ill patients using intensive insulin therapy reduces absolute mortality. It has been reported that pronounced hyperglycemia may lead to complications in such patients, although data from controlled trials are lacking. However, target glycaemia may be difficult to achieve in clinical practice. Insulin adsorption onto infusion equipment (e.g., infusion tubing) may affect glucose control, possibly leading to hyperglycemia. In the use of low-level intravenous insulin infusion for treating diabetic hyperglycaemia and ketoacidosis adsorption of insulin to containers or plastic infusion apparatus results in significant losses of 60-80% of insulin in dilute physiological saline solution.
Problem statement \& Study rationale
Up to my knowledge, there is no study that demonstrate differences between types of dilution for insulin infusion in ICU patient in Malaysia; thus, this study is aimed to evaluate it. In 2001 it has been reported that intensive insulin therapy (IIT) in surgical intensive care unit (ICU) patients was associated with reduction in mortality and morbidity as well as other associated factors. There is limited study in comparing dilution of insulin in normal saline and other types of diluents.
Other than that, it is important to know which diluent the best is to choose for the management of hyperglycaemia in ICU patient.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomized Control Trial
| Arm | Type | Receives |
|---|---|---|
| normal saline | No intervention | –Insulin will be diluted with normal saline crystalloid fluid in 50mls syringe and tubing (same product manufacturer). Blood glucose level will be taken from arterial line at presentation or prior to start insulin and checked using glucometer. Then, at 2 hour and 6 hours after initiation of treatment. |
| gelafundin | Active comparator | Drug: GelafundinInsulin will be diluted with gelafundin colloid fluid in 50mls syringe and tubing (same product manufacturer). Blood glucose level will be taken from arterial line at presentation or prior to start insulin and checked using glucometer. Then, at 2 hour and 6 hours after initiation of treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient admitted to ICU Hospital USM regardless of whether patient intubated or not.
- Adult patient 18 years old and above.
- 2 consecutive blood sugar more than 10 mmol/L including patient with diabetic ketoacidosis and hyperosmolar hyperglycaemic state.
- Within 12 hours from admission.
- Patient not in high inotropic support and with APACHE II score less than 17.
Key exclusion criteria (4 listed)
- Pregnancy.
- History of any allergic from previous gelafundin infusion or known patient to have allergic towards gelafundin (allergic card, or information from relatives)
- Post cardiac arrest or prolonged resuscitation.
- Patient with cardiogenic shock.
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 |
|---|---|---|
| GelafundinInsulin will be diluted with gelafundin colloid fluid in 50mls syringe and tubing (same product manufacturer). Blood glucose level will be taken from arterial line at presentation or prior to start insulin and checked using glucometer. Then, at 2 hour and 6 hours after initiation of treatment. | Drug | gelafundin |
Primary outcome
Blood glucose level
Time frame: At 2 hours
Mean of blood glucose level
Blood glucose level
Time frame: At 6 hours
Mean of blood glucose level
2 secondary outcomes
Mortality
Time frame: 14 days
Mortality
Time frame: 28 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2024.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gelafundin in people with Hyperglycemia, 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 5 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 1 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood glucose level (time frame: At 2 hours). The study lists 2 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 1 May 2024.