Hypoglycemia (Diabetic)RANDOM-IBNCT07056088
Comparing Blood Glucose Control Intraoperative Between Insulin Drip vs. Insulin Boluses Will Provide Valuable Information on the Optimal Method for Achieving Blood Glucose Control Intraoperatively.
A study testing Insulin Drip Therapy and Insulin boluses in people with Hypoglycemia (Diabetic), run by King Faisal Specialist Hospital & Research Center.
Trial summary
Cardiac surgery patients often experience elevated blood glucose levels, which can lead to poor surgical outcomes and increased postoperative complications. Therefore, tight blood glucose control during surgery is important. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypoglycemia (Diabetic)
- What is being tested?
- Insulin Drip Therapy and Insulin boluses
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 384 participants
- Where
- No sites listed yet
- Study dates
- Jul 2025to Aug 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All adult patients (above 18 y of age undergoing Cardiac surgery with preoperative blood glucose level (80 -180 mg/dL)
- Patient with History of diabetes and those taking antidiabetics medications.
Who cannot join
- Patients with known allergy or insulin intolerance.
- Patients with severe hepatic Dysfunction.
- Patient with History of hypoglycemic events in the past 6 month prior to surgery.
About this study
Official title: A Randomized Controlled Trial Comparing Blood Glucose Control Intraoperative Between Insulin Drip vs. Insulin Boluses
Cardiac surgery patients often experience elevated blood glucose levels, which can lead to poor surgical outcomes and increased postoperative complications. Therefore, tight blood glucose control during surgery is important. Currently, there is no consensus on the best method for blood glucose control during cardiac surgery. This proposal aims to perform a randomized controlled trial to compare blood glucose control intraoperatively using an insulin drip versus insulin boluses. The primary objective of the study is to compare blood glucose control intraoperatively between patients who receive insulin drip and patients who receive insulin boluses during adult cardiac surgery. This study will be a randomized controlled trial in which adult patients undergoing cardiac surgery will be randomized into two groups: insulin drip and insulin boluses. Patients with a history of diabetes or those currently taking antidiabetic medications will be included in the study. This randomized controlled trial will provide valuable information on the optimal method for achieving blood glucose control intraoperatively. The results of this study may help improve patient outcomes and reduce the incidence of postoperative complications.
Read the detailed description
Study Title:
A Randomized Controlled Trial Comparing Intraoperative Blood Glucose Control Between Insulin Drip Versus Insulin Boluses in Adult Cardiac Surgery Patients
Sponsor and Funding:
Sponsor: None
Funding Organization: King Faisal Specialist Hospital \& Research Center, Jeddah
Study Site: Single center at King Faisal Specialist Hospital \& Research Center, Jeddah
Background and Rationale:
Maintaining optimal blood glucose levels during cardiac surgery is critical for reducing postoperative complications and improving patient outcomes. Current intraoperative glucose management strategies vary, with insulin administered either continuously via infusion (drip) or intermittently as boluses. This trial investigates which method provides superior glucose control intraoperatively.
Study Design:
This is a prospective, single-center, randomized controlled trial (RCT) with two parallel arms:
Insulin drip group (continuous infusion)
Insulin bolus group (intermittent dosing)
Objectives:
Primary Objective: To compare the effectiveness of insulin drip versus insulin boluses in maintaining intraoperative blood glucose within target ranges during adult cardiac surgery.
Secondary Objectives: To assess the incidence of hypoglycemic events, insulin dose adjustments, duration of ICU stay, lactate clearance, and wound infection rates at 7- and 30-days post-surgery.
Endpoints:
Primary Endpoint: Rate of severe hypoglycemia during surgery.
Secondary Endpoints: ICU length of stay, postoperative lactate clearance, incidence of surgical wound infections at 7- and 30-days post-operation.
Participants:
Sample Size: 384 total participants, randomized equally into two groups (192 per group).
Inclusion Criteria: Adults aged over 18 years undergoing cardiac surgery, preoperative blood glucose between 80-180 mg/dL, with a documented history of diabetes.
Exclusion Criteria: Known intolerance to insulin, severe hepatic dysfunction, recent hypoglycemic episodes.
Intervention Protocols:
Insulin Drip Group: Continuous intravenous insulin infusion initiated at 2 units/hour, titrated to maintain target intraoperative glucose levels.
Insulin Bolus Group: Insulin administered as bolus doses every 30 minutes, adjusted based on glucose monitoring.
Data Collection and Follow-up:
Blood glucose and other relevant clinical parameters are monitored intraoperatively. Participants are followed postoperatively at 1 week, 1 month, 6 months, and 1 year to evaluate long-term outcomes and complications. The total anticipated duration of the trial is 4 years.
Statistical Analysis:
Data analysis will involve calculation of relative risk for hypoglycemia and other categorical outcomes. Time-to-event data will be analyzed using log-rank tests. Statistical significance is defined as p < 0.05.
- Conditions
- Hypoglycemia (Diabetic)
- Being tested
- Insulin Drip Therapy, Insulin boluses
- Medical subject headings
- Hypoglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Insulin Drip TherapyDrug
Simple randomization will be used for randomization. The participants will be randomized into two groups based on methods of insulin delivery.
- Group A: Insulin drip will be administered at a starting rate of 2 units/hour and titrated to maintain blood glucose levels between 80-180 mg/dL.
- Group B: Insulin boluses will be administered every 30 minutes to maintain blood glucose levels between 80-180 mg/dL.
Insulin boluses will be considered as a control group.
Insulin bolusesDrug
Insulin boluses will be administered every 30 minutes to maintain blood glucose levels between 80-180 mg/dL.
Insulin boluses will be considered as a control group
| Study group | Role | What they receive |
|---|---|---|
| Insulin drip | Experimental | Not described Receives: Drug: Insulin Drip Therapy |
| Insulin boluses | Other | Control group Receives: Drug: Insulin boluses |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of severe hypoglycemia
Measured: one year
Secondary outcomes (3)
Duration of ICU stay
Measured: 24 hours
The incidence of wound infection
Measured: 7-30 days
lactate clearance
the percentage decrease in blood lactate concentration
Measured: From the end of surgery to 6 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2025
- Study startJul 2025 (estimated)
- Primary completionAug 2029 (estimated)
- Study completionAug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypoglycemia (Diabetic)Studies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Simple randomization will be used for randomization. The participants will be randomized into two groups based on methods of insulin delivery. * Group A: Insulin drip will be administered at a starting rate of 2 units/hour and titrated to maintain blood glucose levels between 80-180 mg/dL. * Group B: Insulin boluses will be administered every 30 minutes to maintain blood glucose levels between 80-180 mg/dL. Insulin boluses will be considered as a control group.
- Masking
- None (open label)
- Enrolment
- 384 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King Faisal Specialist Hospital & Research Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed Alrefai, King Faisal Specialist Hospital & Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07056088
- Sponsor's protocol ID
- IRB # 2023-45
- Acronym
- RANDOM-IB
- Status last verified
- Jul 2025
- First submitted
- 24 Jun 2025
- Last updated
- 9 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial Comparing Blood Glucose Control Intraoperative Between Insulin Drip vs. Insulin Boluses
- ClinicalTrials.gov ID
- NCT07056088
- Acronym / sponsor ID
- RANDOM-IB / IRB # 2023-45
- Conditions
- Hypoglycemia (Diabetic)
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 384 participants (estimated)
- Lead sponsor
- King Faisal Specialist Hospital & Research CenterUniversity, hospital or other
- Study start
- Jul 2025 (estimated)
- Primary completion
- Aug 2029 (estimated)
- Study completion
- Aug 2029 (estimated)
- First posted
- 9 Jul 2025 (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.
Cardiac surgery patients often experience elevated blood glucose levels, which can lead to poor surgical outcomes and increased postoperative complications. Therefore, tight blood glucose control during surgery is important. Currently, there is no consensus on the best method for blood glucose control during cardiac surgery. This proposal aims to perform a randomized controlled trial to compare blood glucose control intraoperatively using an insulin drip versus insulin boluses. The primary objective of the study is to compare blood glucose control intraoperatively between patients who receive insulin drip and patients who receive insulin boluses during adult cardiac surgery. This study will be a randomized controlled trial in which adult patients undergoing cardiac surgery will be randomized into two groups: insulin drip and insulin boluses. Patients with a history of diabetes or those currently taking antidiabetic medications will be included in the study. This randomized controlled trial will provide valuable information on the optimal method for achieving blood glucose control intraoperatively. The results of this study may help improve patient outcomes and reduce the incidence of postoperative complications.
Detailed description
Study Title:
A Randomized Controlled Trial Comparing Intraoperative Blood Glucose Control Between Insulin Drip Versus Insulin Boluses in Adult Cardiac Surgery Patients
Sponsor and Funding:
Sponsor: None
Funding Organization: King Faisal Specialist Hospital \& Research Center, Jeddah
Study Site: Single center at King Faisal Specialist Hospital \& Research Center, Jeddah
Background and Rationale:
Maintaining optimal blood glucose levels during cardiac surgery is critical for reducing postoperative complications and improving patient outcomes. Current intraoperative glucose management strategies vary, with insulin administered either continuously via infusion (drip) or intermittently as boluses. This trial investigates which method provides superior glucose control intraoperatively.
Study Design:
This is a prospective, single-center, randomized controlled trial (RCT) with two parallel arms:
Insulin drip group (continuous infusion)
Insulin bolus group (intermittent dosing)
Objectives:
Primary Objective: To compare the effectiveness of insulin drip versus insulin boluses in maintaining intraoperative blood glucose within target ranges during adult cardiac surgery.
Secondary Objectives: To assess the incidence of hypoglycemic events, insulin dose adjustments, duration of ICU stay, lactate clearance, and wound infection rates at 7- and 30-days post-surgery.
Endpoints:
Primary Endpoint: Rate of severe hypoglycemia during surgery.
Secondary Endpoints: ICU length of stay, postoperative lactate clearance, incidence of surgical wound infections at 7- and 30-days post-operation.
Participants:
Sample Size: 384 total participants, randomized equally into two groups (192 per group).
Inclusion Criteria: Adults aged over 18 years undergoing cardiac surgery, preoperative blood glucose between 80-180 mg/dL, with a documented history of diabetes.
Exclusion Criteria: Known intolerance to insulin, severe hepatic dysfunction, recent hypoglycemic episodes.
Intervention Protocols:
Insulin Drip Group: Continuous intravenous insulin infusion initiated at 2 units/hour, titrated to maintain target intraoperative glucose levels.
Insulin Bolus Group: Insulin administered as bolus doses every 30 minutes, adjusted based on glucose monitoring.
Data Collection and Follow-up:
Blood glucose and other relevant clinical parameters are monitored intraoperatively. Participants are followed postoperatively at 1 week, 1 month, 6 months, and 1 year to evaluate long-term outcomes and complications. The total anticipated duration of the trial is 4 years.
Statistical Analysis:
Data analysis will involve calculation of relative risk for hypoglycemia and other categorical outcomes. Time-to-event data will be analyzed using log-rank tests. Statistical significance is defined as p < 0.05.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Simple randomization will be used for randomization. The participants will be randomized into two groups based on methods of insulin delivery. * Group A: Insulin drip will be administered at a starting rate of 2 units/hour and titrated to maintain blood glucose levels between 80-180 mg/dL. * Group B: Insulin boluses will be administered every 30 minutes to maintain blood glucose levels between 80-180 mg/dL. Insulin boluses will be considered as a control group.
| Arm | Type | Receives |
|---|---|---|
| Insulin drip | Experimental | Drug: Insulin Drip Therapy |
| Insulin boluses | Other | Drug: Insulin bolusesControl group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- All adult patients (above 18 y of age undergoing Cardiac surgery with preoperative blood glucose level (80 -180 mg/dL)
- Patient with History of diabetes and those taking antidiabetics medications.
Key exclusion criteria (3 listed)
- Patients with known allergy or insulin intolerance.
- Patients with severe hepatic Dysfunction.
- Patient with History of hypoglycemic events in the past 6 month prior to surgery.
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 |
|---|---|---|
| Insulin Drip TherapySimple randomization will be used for randomization. The participants will be randomized into two groups based on methods of insulin delivery. * Group A: Insulin drip will be administered at a starting rate of 2 units/hour and titrated to maintain blood glucose levels between 80-180 mg/dL. * Group B: Insulin boluses will be administered every 30 minutes to maintain blood glucose levels between 80-180 mg/dL. Insulin boluses will be considered as a control group. | Drug | Insulin drip |
| Insulin bolusesInsulin boluses will be administered every 30 minutes to maintain blood glucose levels between 80-180 mg/dL. Insulin boluses will be considered as a control group | Drug | Insulin boluses |
Primary outcome
Rate of severe hypoglycemia
Time frame: one year
3 secondary outcomes
Duration of ICU stay
Time frame: 24 hours
The incidence of wound infection
Time frame: 7-30 days
lactate clearance
Time frame: From the end of surgery to 6 hours postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Insulin Drip Therapy and Insulin boluses in people with Hypoglycemia (Diabetic), run by King Faisal Specialist Hospital & Research Center.
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 2 inclusion and 3 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: opening soon, as of the sponsor's last update on 9 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
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?
Rate of severe hypoglycemia (time frame: one year). 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 9 Jul 2025; AzTrials last refreshed its copy on 6 Nov 2026.