HyperglycemiaNCT04167410
Effect of Perioperative Glycemia Protocol on Glycemic Outcomes in Diabetic Patients Undergoing Abdominal Surgery
A study testing glycaemic management protocol implemented to clinic in people with Hyperglycemia and Perioperative Complication, run by Saglik Bilimleri Universitesi Gulhane Tip Fakultesi at 1 site in Turkey (Türkiye).
Trial summary
This study evaluated to the effects of a glycaemic control protocol directed by nurses during the perioperative period on glycaemic outcomes in diabetic patients undergoing major abdominal surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hyperglycemia, Perioperative Complication
- What is being tested?
- glycaemic management protocol implemented to clinic
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Sep 2017to 1 Mar 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients were diagnosed with type 2 diabetes
- Patients planned to undergo elective major abdominal surgery
Who cannot join
- Patients who had diabetes other than type 2 diabetes
- Patient who had a preoperative glycated haemoglobin A1C (HbA1C) value of 8.5% or greater
- Patient planned to undergo surgery related to the pancreas
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gulhane Research and Training Hospital
Ankara, 06010
About this study
Official title: Effects of Perioperative Glycemic Management Protocol on Glycemic Outcomes of Type 2 Diabetic Patients Undergoing Major Abdominal Surgery: a Non-Randomized Controlled Study
This study evaluated to the effects of a glycaemic control protocol directed by nurses during the perioperative period on glycaemic outcomes in diabetic patients undergoing major abdominal surgery. The study was conducted at the department of general surgery of a research and training hospital.The study included 47 patients who underwent elective major abdominal surgery between September 2017 and December 2018. The number of patients in the intervention and the control groups was 22 and 25, respectively. The glycemia control protocol will be used in the glycemia management of intervention group,routine glycemia management will be used in the control group.
Read the detailed description
The prevalence of diabetes among the surgical patient population is 10-15%, and surgical operations are administered to diabetic patients more frequently compared to non-diabetic patients. Diabetes or hyperglycaemia in surgical patients increases mortality and morbidity rates during the perioperative period by 50% compared to non-diabetic patients. Maintaining patient blood glucose (BG) levels of within the target range during the surgical period is crucial to prevent postoperative complications. The target BG level has been modified in line with recent scientific findings; institutions (such as the American Diabetes Association), have prepared new guidelines for the management of glycaemia in critically ill and surgical patients. Insulin infusion is the most effective method to control glycaemia in patients with critical disease or in patients about to undergo major surgery. Therefore, current guidelines recommend the use of reliable and practical glycaemia control protocols during insulin infusion. These protocols should be learnt by all members of the team that provide healthcare. Existing studies suggest that glycaemic management protocols are effective methods to achieve the target BG range and decrease the prevalence of hyperglycaemia and hypoglycaemia in critically ill and major surgery patients in a reliable and effective way.
- Conditions
- Hyperglycemia, Perioperative Complication
- Being tested
- glycaemic management protocol implemented to clinic
- Keywords
- Perioperative glycaemic management, Nursing, Glycaemic protocol, Glycaemic management, Stress hyperglycaemia, Surgery and diabetes
- Medical subject headings
- Hyperglycemia, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
glycaemic management protocol implemented to clinicOther
Following the introduction of the glycaemic management protocol to the clinic, data on the patients in the intervention group was collected prospectively between June 2018 and December 2018. Data of the patients in the intervention group was collected after the patient applied to the hospital for surgery or just after the decision on surgery was taken. Patients in the intervention group whose HbA1C values exceeded 7% were referred to endocrinology specialists prior to surgery. Glycaemic management of these patients was evaluated at the department of endocrinology and medications or doses of insulin and oral antidiabetics were changed when necessary. Glycaemic management was conducted by nurses in line with the protocolConsequently, the glycaemic management of patients during the perioperative period was conducted by general surgery nurses according to the protocol.
| Study group | Role | What they receive |
|---|---|---|
| control group | No intervention | We did not perform any intervention on the patients in the control group. These patients received routine glycaemia control and healthcare provided to diabetic patients undergoing surgical intervention in the department of general surgery.After receiving written informed consent, the first part of the data collection form on the socio-demographic and disease characteristics of the patients were completed face-to-face. The BG levels of the patients and the medications and insulin used for glycaemic control were recorded one night before surgery. The anxiety levels of the patients were evaluated on the morning of surgery using State-Trait Anxiety Inventory . The second part of the data collection form , which included information on glycaemic management, glycaemia levels and the medications and insulin used on the morning of surgery and during surgery, intensive care stay and the clinical period, was filled in by the nurse on the monitoring and anaesthesia forms. |
| intervention group | Experimental | Following the introduction of the glycaemic management protocol to the clinic, data on the patients in the intervention group was collected prospectively between June 2018 and December 2018. management was conducted by nurses in line with the protocol. Data on glycaemic management of the intervention group was similar to the control group.the glycaemic management of patients during the perioperative period was conducted by general surgery nurses according to the protoco Receives: Other: glycaemic management protocol implemented to clinic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rates of hyperglycaemia development
Capillary BG > 180 mg/dl refers to hyperglycemia.
Measured: Each participant was followed between 7-10 days postoperatively. Data of the control group was collected within 8 months prospectively. Data of the intervention group was collected within 7 months prospectively.
Insulin consumption rate
Insulin consumption of each participant was calculatedIn in the postoperative period.
Measured: Each participant was followed between 7-10 days postoperatively. Data of the control group was collected within 8 months prospectively. Data of the intervention group was collected within 7 months prospectively.
Rates of hypoglycaemia development
Capillary blood glucose (BG) < 70 mg/dl refers to hypoglycemia.
Measured: Each participant was followed between 7-10 days postoperatively. Data of the control group was collected within 8 months prospectively. Data of the intervention group was collected within 7 months prospectively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2019
- Study start15 Sep 2017
- Primary completion15 Dec 2018
- Study completion1 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pervin Gökay, Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
- Investigators
- Pervin Kurtoglu, PhD, Principal investigator, GulhaneResearch and Training Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04167410
- Sponsor's protocol ID
- SBUniversitesi_nursing
- Status last verified
- Jan 2020
- First submitted
- 15 Sep 2019
- Last updated
- 23 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De identifield individual participant data for all primary and secondary outcomes measures will be made available
Publications
Compton F, Ahlborn R, Weidehoff T. Nurse-Directed Blood Glucose Management in a Medical Intensive Care Unit. Crit Care Nurse. 2017 Jun;37(3):30-40. doi: 10.4037/ccn2017922.
PubMed 28572099Duggan EW, Carlson K, Umpierrez GE. Perioperative Hyperglycemia Management: An Update. Anesthesiology. 2017 Mar;126(3):547-560. doi: 10.1097/ALN.0000000000001515.
PubMed 28121636
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Perioperative Glycemic Management Protocol on Glycemic Outcomes of Type 2 Diabetic Patients Undergoing Major Abdominal Surgery: a Non-Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT04167410
- Acronym / sponsor ID
- SBUniversitesi_nursing
- Conditions
- Hyperglycemia, Perioperative Complication
- Keywords
- Perioperative glycaemic management, Nursing, Glycaemic protocol, Glycaemic management, Stress hyperglycaemia, Surgery and diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Saglik Bilimleri Universitesi Gulhane Tip FakultesiUniversity, hospital or other
- Study start
- 15 Sep 2017 (actual)
- Primary completion
- 15 Dec 2018 (actual)
- Study completion
- 1 Mar 2019 (actual)
- First posted
- 18 Nov 2019 (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.
This study evaluated to the effects of a glycaemic control protocol directed by nurses during the perioperative period on glycaemic outcomes in diabetic patients undergoing major abdominal surgery. The study was conducted at the department of general surgery of a research and training hospital.The study included 47 patients who underwent elective major abdominal surgery between September 2017 and December 2018. The number of patients in the intervention and the control groups was 22 and 25, respectively. The glycemia control protocol will be used in the glycemia management of intervention group,routine glycemia management will be used in the control group.
Detailed description
The prevalence of diabetes among the surgical patient population is 10-15%, and surgical operations are administered to diabetic patients more frequently compared to non-diabetic patients. Diabetes or hyperglycaemia in surgical patients increases mortality and morbidity rates during the perioperative period by 50% compared to non-diabetic patients. Maintaining patient blood glucose (BG) levels of within the target range during the surgical period is crucial to prevent postoperative complications. The target BG level has been modified in line with recent scientific findings; institutions (such as the American Diabetes Association), have prepared new guidelines for the management of glycaemia in critically ill and surgical patients. Insulin infusion is the most effective method to control glycaemia in patients with critical disease or in patients about to undergo major surgery. Therefore, current guidelines recommend the use of reliable and practical glycaemia control protocols during insulin infusion. These protocols should be learnt by all members of the team that provide healthcare. Existing studies suggest that glycaemic management protocols are effective methods to achieve the target BG range and decrease the prevalence of hyperglycaemia and hypoglycaemia in critically ill and major surgery patients in a reliable and effective way.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | No intervention | –We did not perform any intervention on the patients in the control group. These patients received routine glycaemia control and healthcare provided to diabetic patients undergoing surgical intervention in the department of general surgery.After receiving written informed consent, the first part of the data collection form on the socio-demographic and disease characteristics of the patients were completed face-to-face. The BG levels of the patients and the medications and insulin used for glycaemic control were recorded one night before surgery. The anxiety levels of the patients were evaluated on the morning of surgery using State-Trait Anxiety Inventory . The second part of the data collection form , which included information on glycaemic management, glycaemia levels and the medications and insulin used on the morning of surgery and during surgery, intensive care stay and the clinical period, was filled in by the nurse on the monitoring and anaesthesia forms. |
| intervention group | Experimental | Other: glycaemic management protocol implemented to clinicFollowing the introduction of the glycaemic management protocol to the clinic, data on the patients in the intervention group was collected prospectively between June 2018 and December 2018. management was conducted by nurses in line with the protocol. Data on glycaemic management of the intervention group was similar to the control group.the glycaemic management of patients during the perioperative period was conducted by general surgery nurses according to the protoco |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients were diagnosed with type 2 diabetes
- Patients planned to undergo elective major abdominal surgery
Key exclusion criteria (3 listed)
- Patients who had diabetes other than type 2 diabetes
- Patient who had a preoperative glycated haemoglobin A1C (HbA1C) value of 8.5% or greater
- Patient planned to undergo surgery related to the pancreas
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 |
|---|---|---|
| glycaemic management protocol implemented to clinicFollowing the introduction of the glycaemic management protocol to the clinic, data on the patients in the intervention group was collected prospectively between June 2018 and December 2018. Data of the patients in the intervention group was collected after the patient applied to the hospital for surgery or just after the decision on surgery was taken. Patients in the intervention group whose HbA1C values exceeded 7% were referred to endocrinology specialists prior to surgery. Glycaemic management of these patients was evaluated at the department of endocrinology and medications or doses of insulin and oral antidiabetics were changed when necessary. Glycaemic management was conducted by nurses in line with the protocolConsequently, the glycaemic management of patients during the perioperative period was conducted by general surgery nurses according to the protocol. | Other | intervention group |
Primary outcome
Rates of hyperglycaemia development
Time frame: Each participant was followed between 7-10 days postoperatively. Data of the control group was collected within 8 months prospectively. Data of the intervention group was collected within 7 months prospectively.
Capillary BG > 180 mg/dl refers to hyperglycemia.
Insulin consumption rate
Time frame: Each participant was followed between 7-10 days postoperatively. Data of the control group was collected within 8 months prospectively. Data of the intervention group was collected within 7 months prospectively.
Insulin consumption of each participant was calculatedIn in the postoperative period.
Rates of hypoglycaemia development
Time frame: Each participant was followed between 7-10 days postoperatively. Data of the control group was collected within 8 months prospectively. Data of the intervention group was collected within 7 months prospectively.
Capillary blood glucose (BG) < 70 mg/dl refers to hypoglycemia.
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 23 Jan 2020.
- Background: PubMed 28572099Compton F, Ahlborn R, Weidehoff T. Nurse-Directed Blood Glucose Management in a Medical Intensive Care Unit. Crit Care Nurse. 2017 Jun;37(3):30-40. doi: 10.4037/ccn2017922.
- Background: PubMed 28121636Duggan EW, Carlson K, Umpierrez GE. Perioperative Hyperglycemia Management: An Update. Anesthesiology. 2017 Mar;126(3):547-560. doi: 10.1097/ALN.0000000000001515.
- Individual participant dataSharing planned: Yes. De identifield individual participant data for all primary and secondary outcomes measures will be made available
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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.
Pervin Kurtoglu, PhD principal investigator
GulhaneResearch and Training Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing glycaemic management protocol implemented to clinic in people with Hyperglycemia and Perioperative Complication, run by Saglik Bilimleri Universitesi Gulhane Tip Fakultesi at 1 site in Turkey (Türkiye).
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: finished, as of the sponsor's last update on 23 Jan 2020. 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 Turkey (Türkiye). 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?
Rates of hyperglycaemia development (time frame: Each participant was followed between 7-10 days postoperatively. Data of the control group was collected within 8 months prospectively. Data of the intervention group was collected within 7 months prospectively.). 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?
On the ClinicalTrials.gov record for NCT04167410, which also lists 2 linked publications.
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 23 Jan 2020.