Intraoperative ComplicationsEarly Phase 1NCT05136157
Intravenous Bolus-infusion Versus Sliding Scale of Insulin for Intra-operative Glycemic Control
A Early Phase 1 study testing Rapid-Acting Insulin in people with Intraoperative Complications, run by Ain Shams University at 1 site in Egypt.
Trial summary
Pre-operative blood glucose (BG) concentrations in type 2 diabetic patients undergoing elective non-cardiac surgery; have an increased incidence of in-hospital morbidity for cardiopulmonary and infectious complications. Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Intraoperative Complications
- What is being tested?
- Rapid-Acting Insulin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2021to 15 Jul 2022
- Phase
- Early Phase 1
- 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 21 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA physical status II patients
- aged 21-65 years
- known to have type1 or 2 diabetes mellitusw
- pre-operative fasting blood glucose level ˂ 350 mg/dl
- scheduled to undergo elective laparotomy surgeries
- expected to exceed 2 hours duration under general anesthesia
Who cannot join
- Patients' refusal
- diabetic ketoacidosis
- hyperglycemic hyperosmolar syndrome
- serum potassium ˂3.5 mEq/L
- HbA1c >8.5%.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intravenous Bolus-infusion Versus Sliding Scale of Insulin for Intra-operative Glycemic Control in Elective Laparotomy Surgeries
Pre-operative blood glucose (BG) concentrations in type 2 diabetic patients undergoing elective non-cardiac surgery; have an increased incidence of in-hospital morbidity for cardiopulmonary and infectious complications. Also, hyperglycemia is associated with increased production and impaired scavenging of oxygen reactive species, polymorph nuclear neutrophil dysfunction and decreased intracellular killing, resulting in poor wound healing and increased risk of infection. Thus, perioperative optimal glucose management contributes to reduced morbidity and mortality. Recommendations favor moderate levels of capillary blood glucose (CBG); maintaining it in the range of 140-180 mg/dl.
Peri-operative doses of rapidly acting insulin for glycemic control could be done by the sliding scale or the bolus-infusion approaches. The sliding scale of insulin is commonly used to manage peri-operative hyper-glycaemia. It involves administering prescribed doses of insulin when the CBG is within determined ranges and withholding insulin when the CBG is within normal range. When used as a sole therapy; it results in under-insulinisation and thus hyper-glycaemia. The use of a dynamic insulin regimen like the intravenous bolus-infusion approach; allows adjusting the blood glucose level according to the insulin sensitivity of each patient, thus, better glucose control and less variations than the intermittent intravenous bolus of short-acting insulin in the sliding scale despite the same blood glucose target.
Read the detailed description
compare the rapidly acting insulin injection via the bolus-infusion approach (Study group) to the sliding scale approach (Control group) as regards the intra-operative glycemic control
- Conditions
- Intraoperative Complications
- Being tested
- Rapid-Acting Insulin
- Keywords
- Insulin, Intra operative, Sliding scale, Bolus- infusion
- Medical subject headings
- Intraoperative Complications, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rapid-Acting InsulinDrug
Also called Crystalline insulin
50 IU of rapid acting insulin taken by a 100 units (1ml) insulin syringe will be added to a 50 ml syringe containing normal saline (NS) to have a total volume of 50 ml with a concentration of 1 IU of insulin per 1 ml of NS
| Study group | Role | What they receive |
|---|---|---|
| Study group | Active comparator | Bolus-Infusion approach of rapidly acting crystalline insulin. The patient intra-operative blood glucose will be divided by 100. The resultant rapidly acting crystalline insulin units will be given intravenously over 10 minutes, and then continued as an intra-venous infusion per hour. The Capillary Blood Glucose (CBG) will be measured every 30 minutes and in the PACU with readjustment of the bolus-infusion dose as required Receives: Drug: Rapid-Acting Insulin |
| Control group | Active comparator | The sliding scale approach of rapidly acting crystalline insulin will be used according to the intra-operative blood glucose; 4 IU of insulin will be given when the CBG 180-250 mg/dl, 6 IU of insulin will be given when the CBG 251-300 mg/dl, 8 IU of insulin will be given when the CBG 301-350 mg/dl and 10 IU of insulin will be given when the CBG 351-400 mg/dl (5). The CBG will be measured every 30 minutes and in the PACU. Receives: Drug: Rapid-Acting Insulin |
What is being measured
The primary outcome is the main question the study is designed to answer.
intra-operative CBG level between 140- 180 mg/dl all over the operation
Base line CBG will be measured for all patients then every 30 minutes and in the PACU
Measured: 7 months
Secondary outcomes (2)
Total IU of rapidly acting insulin given to the patient
total units of insulin given to the patient will be calculated in the PACU
Measured: 7 months
Peri-operative changes in serum potassium
Base line serum potassium will be compared to that measured in the PACU
Measured: 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2021
- Study start1 Nov 2021
- Primary completion25 May 2022
- Study completion15 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intraoperative ComplicationsStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ghada M.Samir, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05136157
- Sponsor's protocol ID
- R 16/2020/2021
- Status last verified
- Oct 2022
- First submitted
- 8 Oct 2021
- Last updated
- 25 Oct 2022
- Results posted
- 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 25 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravenous Bolus-infusion Versus Sliding Scale of Insulin for Intra-operative Glycemic Control in Elective Laparotomy Surgeries
- ClinicalTrials.gov ID
- NCT05136157
- Acronym / sponsor ID
- R 16/2020/2021
- Conditions
- Intraoperative Complications
- Keywords
- Insulin, Intra operative, Sliding scale, Bolus- infusion
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 25 May 2022 (actual)
- Study completion
- 15 Jul 2022 (actual)
- First posted
- 29 Nov 2021 (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.
Pre-operative blood glucose (BG) concentrations in type 2 diabetic patients undergoing elective non-cardiac surgery; have an increased incidence of in-hospital morbidity for cardiopulmonary and infectious complications. Also, hyperglycemia is associated with increased production and impaired scavenging of oxygen reactive species, polymorph nuclear neutrophil dysfunction and decreased intracellular killing, resulting in poor wound healing and increased risk of infection. Thus, perioperative optimal glucose management contributes to reduced morbidity and mortality. Recommendations favor moderate levels of capillary blood glucose (CBG); maintaining it in the range of 140-180 mg/dl.
Peri-operative doses of rapidly acting insulin for glycemic control could be done by the sliding scale or the bolus-infusion approaches. The sliding scale of insulin is commonly used to manage peri-operative hyper-glycaemia. It involves administering prescribed doses of insulin when the CBG is within determined ranges and withholding insulin when the CBG is within normal range. When used as a sole therapy; it results in under-insulinisation and thus hyper-glycaemia. The use of a dynamic insulin regimen like the intravenous bolus-infusion approach; allows adjusting the blood glucose level according to the insulin sensitivity of each patient, thus, better glucose control and less variations than the intermittent intravenous bolus of short-acting insulin in the sliding scale despite the same blood glucose target.
Detailed description
compare the rapidly acting insulin injection via the bolus-infusion approach (Study group) to the sliding scale approach (Control group) as regards the intra-operative glycemic control
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group | Active comparator | Drug: Rapid-Acting InsulinBolus-Infusion approach of rapidly acting crystalline insulin. The patient intra-operative blood glucose will be divided by 100. The resultant rapidly acting crystalline insulin units will be given intravenously over 10 minutes, and then continued as an intra-venous infusion per hour. The Capillary Blood Glucose (CBG) will be measured every 30 minutes and in the PACU with readjustment of the bolus-infusion dose as required |
| Control group | Active comparator | Drug: Rapid-Acting InsulinThe sliding scale approach of rapidly acting crystalline insulin will be used according to the intra-operative blood glucose; 4 IU of insulin will be given when the CBG 180-250 mg/dl, 6 IU of insulin will be given when the CBG 251-300 mg/dl, 8 IU of insulin will be given when the CBG 301-350 mg/dl and 10 IU of insulin will be given when the CBG 351-400 mg/dl (5). The CBG will be measured every 30 minutes and in the PACU. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- ASA physical status II patients
- aged 21-65 years
- known to have type1 or 2 diabetes mellitusw
- pre-operative fasting blood glucose level ˂ 350 mg/dl
- scheduled to undergo elective laparotomy surgeries
Key exclusion criteria (5 listed)
- Patients' refusal
- diabetic ketoacidosis
- hyperglycemic hyperosmolar syndrome
- serum potassium ˂3.5 mEq/L
- HbA1c >8.5%.
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 |
|---|---|---|
| Rapid-Acting InsulinAlso: Crystalline insulin50 IU of rapid acting insulin taken by a 100 units (1ml) insulin syringe will be added to a 50 ml syringe containing normal saline (NS) to have a total volume of 50 ml with a concentration of 1 IU of insulin per 1 ml of NS | Drug | Control group, Study group |
Primary outcome
intra-operative CBG level between 140- 180 mg/dl all over the operation
Time frame: 7 months
Base line CBG will be measured for all patients then every 30 minutes and in the PACU
2 secondary outcomes
Total IU of rapidly acting insulin given to the patient
Time frame: 7 months
Peri-operative changes in serum potassium
Time frame: 7 months
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 25 Oct 2022.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Rapid-Acting Insulin in people with Intraoperative Complications, run by Ain Shams University at 1 site in Egypt.
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 6 inclusion and 5 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 25 Oct 2022. 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 Egypt. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
intra-operative CBG level between 140- 180 mg/dl all over the operation (time frame: 7 months). 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 25 Oct 2022.