InflammationNCT00995501
The Effects of Corticosteroids, Glucose Control, and Depth-of-Anesthesia on Perioperative Inflammation and Morbidity From Major Non-cardiac Surgery (Dexamethasone, Light Anesthesia and Tight Glucose Control (DeLiT Trial))
A study testing Dexamethasone Sodium Sulfate, Insulin and anesthesia management in people with Inflammation and Perioperative Morbidity, run by d sessler at 1 site in United States.
Trial summary
Evidence thus suggests that steroid administration, tight glucose control, and avoidance of deep anesthesia may decrease perioperative morbidity by reducing the inflammatory response to surgery. Read more about this study
- Who is it for?
- Ages 40 to 90 years
- Conditions the study is for
- Inflammation, Perioperative Morbidity
- What is being tested?
- Dexamethasone Sodium Sulfate, Insulin and anesthesia management
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 381 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2007to Dec 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 40 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥40 years old.
- Major non-cardiac surgical procedures scheduled to take ≥ two hours done under general anesthesia.
- Written informed consent
Who cannot join
- Recent intravenous or oral steroid therapy (within 30 days); inhaled steroids are permitted
- Any contraindications to the proposed interventions
- ASA Physical Status > 4
- Non English speaking patients
- Procedures done under regional anesthesia
Trial locations and contacts
1 site in 1 country.
About this study
Evidence thus suggests that steroid administration, tight glucose control, and avoidance of deep anesthesia may decrease perioperative morbidity by reducing the inflammatory response to surgery. Using a three-way factorial approach, the investigators thus propose to test the primary hypotheses that major perioperative morbidity is reduced by: 1) low-dose dexamethasone; 2) intensive perioperative glucose control; and 3) lighter anesthesia.
Secondary hypotheses include that each intervention reduces circulating concentrations of the inflammatory marker CRP, and that there is a correlation between C-reactive protein (CRP) and post-operative complications. Anesthetic sensitivity predicts major and minor complications, and delirium Other secondary hypotheses are that each intervention, reduces minor surgical complications, reduces postoperative nausea and vomiting (PONV), reduces postoperative delirium, speeds hospital discharge, improves quality of life (SF-12v2 Health Survey, Christensen's VAS fatigue score), and reduces all-cause one-year mortality.
Read the detailed description
The perioperative period is characterized by an intense inflammatory response marked by elevated concentrations of inflammatory markers like C-Reactive Protein (CRP). This response has been linked to increased perioperative morbidity and mortality. Available evidence suggests that blunting the inflammatory response to surgical trauma might improve perioperative outcomes. The putative benefits from blunting the surgical stress response are likely to be greatest in high-risk patients such as those having major non-cardiac surgery. We will study three interventions potentially modulating perioperative inflammation, corticosteroids, tight glucose control and light anesthesia and their effects on major morbidity and mortality resulting from major non-cardiac surgery.
Steroids are the most powerful routinely available anti-inflammatory drugs. They decrease perioperative concentrations of inflammatory markers and improve outcomes after cardiac and abdominal surgery.
Poorly controlled blood glucose worsens the inflammatory response to surgery. Hyperglycemia impairs wound healing, increases infection risk, increases overall hospital mortality, increases the risk of perioperative renal failure, and augments transfusion requirements. Treatment of hyperglycemia has been shown to improve outcomes and decrease mortality in cardiac patients. Also in critically ill patients, it decreased inflammatory markers, overall hospital mortality by 34%, blood stream infections by 46%, and acute renal failure by 41%.
Cumulative deep hypnotic time is associated with increased one-year all-cause mortality, possibly through aggravation of the inflammatory response to surgery. In contrast, avoidance of deep anesthesia appears to reduce postoperative CRP levels, the risk of nausea and vomiting, as well as postoperative hemodynamic, respiratory and infectious complications.
Evidence thus suggests that steroid administration, tight glucose control, and avoidance of deep anesthesia may decrease perioperative morbidity by reducing the inflammatory response to surgery. Using a three-way factorial approach, we thus propose to test the primary hypotheses that major perioperative morbidity is reduced by: 1) low-dose dexamethasone; 2) intensive perioperative glucose control; and, 3) lighter anesthesia.
Secondary hypotheses include that each intervention reduces circulating concentrations of the inflammatory marker CRP, and that there is a correlation between CRP and post-operative complications. Anesthetic sensitivity predicts major and minor complications, and delirium Other secondary hypotheses are that each intervention, reduces minor surgical complications, reduces postoperative nausea and vomiting (PONV), reduces postoperative delirium, speeds hospital discharge, improves quality of life (SF-12v2 Health Survey, Christensen's VAS fatigue score), and reduces all-cause one-year mortality.
- Conditions
- Inflammation, Perioperative Morbidity
- Being tested
- Dexamethasone Sodium Sulfate, Insulin, anesthesia management, Dexamethasone - placebo, Insulin - Placebo
- Keywords
- steroid administration, tight glucose control, light anesthesiReducing inflammatory response to surgical stress, a
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexamethasone Sodium SulfateDrug
8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning
InsulinDrug
Insulin to maintain blood glucose 80-110 mg/dl.
anesthesia managementDrug
Light anesthesia to maintain BIS about 55
Dexamethasone - placeboOther
8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning
Insulin - PlaceboOther
Insulin to maintain blood glucose 180-200 mg/dl.
Anesthesia management -PlaceboOther
Deep anesthesia to maintain BIS about 35
| Study group | Role | What they receive |
|---|---|---|
| Intensive Glucose Control, Dexamethasone, light anesthesia | Active comparator | * Intensive Glucose Control The target range for blood glucose will be 80-110 mg/dl
* Dexamethasone Dexamethasone administered at 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning.
* Light anesthesia target BIS of 55 Receives: Drug: Dexamethasone Sodium Sulfate; Drug: Insulin; Drug: anesthesia management |
| Intensive Glucose Control, Dexamethasone, Deep anesthesia | Active comparator | * Intensive Glucose Control The target range for blood glucose will be 80-110 mg/dl
* Dexamethasone Dexamethasone administered at 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning.
* Deep anesthesia target BIS of 35 Receives: Drug: Dexamethasone Sodium Sulfate; Drug: Insulin; Other: Anesthesia management -Placebo |
| Intensive Glucose Control, placebo, Light anesthesia | Active comparator | * Intensive Glucose Control The target range for blood glucose will be 80-110 mg/dl
* Placebo Placebo administered at 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning.
* Light anesthesia target BIS of 55 Receives: Drug: Dexamethasone Sodium Sulfate; Drug: anesthesia management; Other: Insulin - Placebo |
| Conventional Glucose Control, Dexamethasone, Light anesthesia | Active comparator | * Conventional Glucose Control The target range for blood glucose will be 180-200 mg/dl
* Dexamethasone Dexamethasone administered at 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning.
* Light anesthesia target BIS of 55 Receives: Drug: Insulin; Drug: anesthesia management; Other: Dexamethasone - placebo |
| Intensive Glucose Control, Placebo, Deep anesthesia | Active comparator | * Intensive Glucose Control The target range for blood glucose will be 80-110 mg/dl
* Placebo Placebo administered at 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning.
* Deep anesthesia target BIS of 35 Receives: Drug: Dexamethasone Sodium Sulfate; Other: Insulin - Placebo; Other: Anesthesia management -Placebo |
| Conventional Glucose Control, Dexamethasone, Deep anesthesia | Active comparator | * Conventional Glucose Control The target range for blood glucose will be 180-200 mg/dl
* Dexamethasone Dexamethasone administered at 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning.
* Deep anesthesia target BIS of 35 Receives: Drug: Insulin; Other: Dexamethasone - placebo; Other: Anesthesia management -Placebo |
| Conventional Glucose Control, Placebo, Light anesthesia | Active comparator | * Conventional Glucose Control The target range for blood glucose will be 180-200 mg/dl
* Placebo Placebo administered at 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning.
* Light anesthesia target BIS of 55 Receives: Drug: anesthesia management; Other: Dexamethasone - placebo; Other: Insulin - Placebo |
| Conventional Glucose Control, Placebo, Deep anesthesia | Placebo comparator | * Conventional Glucose Control The target range for blood glucose will be 180-200 mg/dl
* Placebo Placebo administered at 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning.
* Deep anesthesia target BIS of 35 Receives: Other: Dexamethasone - placebo; Other: Insulin - Placebo; Other: Anesthesia management -Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major Perioperative Morbidity
Our primary outcome was a collapsed composite endpoint (any versus none) defined as the occurrence of at least one of sixteen major complications before hospital discharge, including sepsis, severe surgical site infection, myocardial infarction, heart failure, stroke, unstable ventricular arrhythmias, pulmonary embolism, pneumonia, respiratory failure, dialysis dependent renal failure, large pleural or peritoneal effusions, major bleeding, major wound and surgical site healing complications, vascular graft thrombosis, and 30-day mortality.
Measured: 30 day after surgery
Secondary outcomes (1)
1 Year Mortality
All-cause mortality
Measured: 1 year after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2009 (estimated)
- Study startJan 2007
- Primary completionDec 2015
- Study completionDec 2015
Why it stopped: Per interim analysis, for futility.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for InflammationStudies 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
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 381 participants (actual)
Sponsor and investigators
- Lead sponsor
- d sessler
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, d sessler, The Cleveland Clinic
- Investigators
- Basem Abdelmalak, MD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00995501
- Sponsor's protocol ID
- 07-010
- Status last verified
- Mar 2017
- First submitted
- 14 Oct 2009
- Last updated
- 25 Apr 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Bellon F, Sola I, Gimenez-Perez G, Hernandez M, Metzendorf MI, Rubinat E, Mauricio D. Perioperative glycaemic control for people with diabetes undergoing surgery. Cochrane Database Syst Rev. 2023 Aug 1;8(8):CD007315. doi: 10.1002/14651858.CD007315.pub3.
PubMed 37526194Abdelmalak BB, Duncan AE, Bonilla A, Yang D, Parra-Sanchez I, Fergany A, Irefin SA, Sessler DI. The intraoperative glycemic response to intravenous insulin during noncardiac surgery: a subanalysis of the DeLiT randomized trial. J Clin Anesth. 2016 Mar;29:19-29. doi: 10.1016/j.jclinane.2015.10.005. Epub 2016 Feb 2.
PubMed 26897443Abdelmalak BB, Bonilla A, Mascha EJ, Maheshwari A, Tang WH, You J, Ramachandran M, Kirkova Y, Clair D, Walsh RM, Kurz A, Sessler DI. Dexamethasone, light anaesthesia, and tight glucose control (DeLiT) randomized controlled trial. Br J Anaesth. 2013 Aug;111(2):209-21. doi: 10.1093/bja/aet050. Epub 2013 Mar 28.
PubMed 23539236Abdelmalak B, Maheshwari A, Kovaci B, Mascha EJ, Cywinski JB, Kurz A, Kashyap VS, Sessler DI. Validation of the DeLiT Trial intravenous insulin infusion algorithm for intraoperative glucose control in noncardiac surgery: a randomized controlled trial. Can J Anaesth. 2011 Jul;58(7):606-616. doi: 10.1007/s12630-011-9509-3. Epub 2011 May 20.
PubMed 21598057
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Corticosteroids, Glucose Control, and Depth-of-Anesthesia on Perioperative Inflammation and Morbidity From Major Non-cardiac Surgery (Dexamethasone, Light Anesthesia and Tight Glucose Control (DeLiT Trial))
- ClinicalTrials.gov ID
- NCT00995501
- Acronym / sponsor ID
- 07-010
- Conditions
- Inflammation, Perioperative Morbidity
- Keywords
- steroid administration, tight glucose control, light anesthesiReducing inflammatory response to surgical stress, a
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Per interim analysis, for futility.
- Enrolment
- 381 participants (actual)
- Lead sponsor
- d sesslerUniversity, hospital or other
- Study start
- Jan 2007
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 15 Oct 2009 (estimated)
- Results
- Posted 25 Apr 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evidence thus suggests that steroid administration, tight glucose control, and avoidance of deep anesthesia may decrease perioperative morbidity by reducing the inflammatory response to surgery. Using a three-way factorial approach, the investigators thus propose to test the primary hypotheses that major perioperative morbidity is reduced by: 1) low-dose dexamethasone; 2) intensive perioperative glucose control; and 3) lighter anesthesia.
Secondary hypotheses include that each intervention reduces circulating concentrations of the inflammatory marker CRP, and that there is a correlation between C-reactive protein (CRP) and post-operative complications. Anesthetic sensitivity predicts major and minor complications, and delirium Other secondary hypotheses are that each intervention, reduces minor surgical complications, reduces postoperative nausea and vomiting (PONV), reduces postoperative delirium, speeds hospital discharge, improves quality of life (SF-12v2 Health Survey, Christensen's VAS fatigue score), and reduces all-cause one-year mortality.
Detailed description
The perioperative period is characterized by an intense inflammatory response marked by elevated concentrations of inflammatory markers like C-Reactive Protein (CRP). This response has been linked to increased perioperative morbidity and mortality. Available evidence suggests that blunting the inflammatory response to surgical trauma might improve perioperative outcomes. The putative benefits from blunting the surgical stress response are likely to be greatest in high-risk patients such as those having major non-cardiac surgery. We will study three interventions potentially modulating perioperative inflammation, corticosteroids, tight glucose control and light anesthesia and their effects on major morbidity and mortality resulting from major non-cardiac surgery.
Steroids are the most powerful routinely available anti-inflammatory drugs. They decrease perioperative concentrations of inflammatory markers and improve outcomes after cardiac and abdominal surgery.
Poorly controlled blood glucose worsens the inflammatory response to surgery. Hyperglycemia impairs wound healing, increases infection risk, increases overall hospital mortality, increases the risk of perioperative renal failure, and augments transfusion requirements. Treatment of hyperglycemia has been shown to improve outcomes and decrease mortality in cardiac patients. Also in critically ill patients, it decreased inflammatory markers, overall hospital mortality by 34%, blood stream infections by 46%, and acute renal failure by 41%.
Cumulative deep hypnotic time is associated with increased one-year all-cause mortality, possibly through aggravation of the inflammatory response to surgery. In contrast, avoidance of deep anesthesia appears to reduce postoperative CRP levels, the risk of nausea and vomiting, as well as postoperative hemodynamic, respiratory and infectious complications.
Evidence thus suggests that steroid administration, tight glucose control, and avoidance of deep anesthesia may decrease perioperative morbidity by reducing the inflammatory response to surgery. Using a three-way factorial approach, we thus propose to test the primary hypotheses that major perioperative morbidity is reduced by: 1) low-dose dexamethasone; 2) intensive perioperative glucose control; and, 3) lighter anesthesia.
Secondary hypotheses include that each intervention reduces circulating concentrations of the inflammatory marker CRP, and that there is a correlation between CRP and post-operative complications. Anesthetic sensitivity predicts major and minor complications, and delirium Other secondary hypotheses are that each intervention, reduces minor surgical complications, reduces postoperative nausea and vomiting (PONV), reduces postoperative delirium, speeds hospital discharge, improves quality of life (SF-12v2 Health Survey, Christensen's VAS fatigue score), and reduces all-cause one-year mortality.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, investigator)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Intensive Glucose Control, Dexamethasone, light anesthesia | Active comparator | Drug: Dexamethasone Sodium Sulfate, Drug: Insulin, Drug: anesthesia management* Intensive Glucose Control The target range for blood glucose will be 80-110 mg/dl * Dexamethasone Dexamethasone administered at 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning. * Light anesthesia target BIS of 55 |
| Intensive Glucose Control, Dexamethasone, Deep anesthesia | Active comparator | Drug: Dexamethasone Sodium Sulfate, Drug: Insulin, Other: Anesthesia management -Placebo* Intensive Glucose Control The target range for blood glucose will be 80-110 mg/dl * Dexamethasone Dexamethasone administered at 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning. * Deep anesthesia target BIS of 35 |
| Intensive Glucose Control, placebo, Light anesthesia | Active comparator | Drug: Dexamethasone Sodium Sulfate, Drug: anesthesia management, Other: Insulin - Placebo* Intensive Glucose Control The target range for blood glucose will be 80-110 mg/dl * Placebo Placebo administered at 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning. * Light anesthesia target BIS of 55 |
| Conventional Glucose Control, Dexamethasone, Light anesthesia | Active comparator | Drug: Insulin, Drug: anesthesia management, Other: Dexamethasone - placebo* Conventional Glucose Control The target range for blood glucose will be 180-200 mg/dl * Dexamethasone Dexamethasone administered at 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning. * Light anesthesia target BIS of 55 |
| Intensive Glucose Control, Placebo, Deep anesthesia | Active comparator | Drug: Dexamethasone Sodium Sulfate, Other: Insulin - Placebo, Other: Anesthesia management -Placebo* Intensive Glucose Control The target range for blood glucose will be 80-110 mg/dl * Placebo Placebo administered at 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning. * Deep anesthesia target BIS of 35 |
| Conventional Glucose Control, Dexamethasone, Deep anesthesia | Active comparator | Drug: Insulin, Other: Dexamethasone - placebo, Other: Anesthesia management -Placebo* Conventional Glucose Control The target range for blood glucose will be 180-200 mg/dl * Dexamethasone Dexamethasone administered at 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning. * Deep anesthesia target BIS of 35 |
| Conventional Glucose Control, Placebo, Light anesthesia | Active comparator | Drug: anesthesia management, Other: Dexamethasone - placebo, Other: Insulin - Placebo* Conventional Glucose Control The target range for blood glucose will be 180-200 mg/dl * Placebo Placebo administered at 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning. * Light anesthesia target BIS of 55 |
| Conventional Glucose Control, Placebo, Deep anesthesia | Placebo comparator | Other: Dexamethasone - placebo, Other: Insulin - Placebo, Other: Anesthesia management -Placebo* Conventional Glucose Control The target range for blood glucose will be 180-200 mg/dl * Placebo Placebo administered at 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning. * Deep anesthesia target BIS of 35 |
Who may qualify
- Ages
- 40 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥40 years old.
- Major non-cardiac surgical procedures scheduled to take ≥ two hours done under general anesthesia.
- Written informed consent
Key exclusion criteria (5 listed)
- Recent intravenous or oral steroid therapy (within 30 days); inhaled steroids are permitted
- Any contraindications to the proposed interventions
- ASA Physical Status > 4
- Non English speaking patients
- Procedures done under regional anesthesia
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 |
|---|---|---|
| Dexamethasone Sodium Sulfate8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning | Drug | Intensive Glucose Control, Dexamethasone, Deep anesthesia, Intensive Glucose Control, Dexamethasone, light anesthesia, Intensive Glucose Control, Placebo, Deep anesthesia, Intensive Glucose Control, placebo, Light anesthesia |
| InsulinInsulin to maintain blood glucose 80-110 mg/dl. | Drug | Conventional Glucose Control, Dexamethasone, Deep anesthesia, Conventional Glucose Control, Dexamethasone, Light anesthesia, Intensive Glucose Control, Dexamethasone, Deep anesthesia, Intensive Glucose Control, Dexamethasone, light anesthesia |
| anesthesia managementLight anesthesia to maintain BIS about 55 | Drug | Conventional Glucose Control, Dexamethasone, Light anesthesia, Conventional Glucose Control, Placebo, Light anesthesia, Intensive Glucose Control, Dexamethasone, light anesthesia, Intensive Glucose Control, placebo, Light anesthesia |
| Dexamethasone - placebo8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning | Other | Conventional Glucose Control, Dexamethasone, Deep anesthesia, Conventional Glucose Control, Dexamethasone, Light anesthesia, Conventional Glucose Control, Placebo, Deep anesthesia, Conventional Glucose Control, Placebo, Light anesthesia |
| Insulin - PlaceboInsulin to maintain blood glucose 180-200 mg/dl. | Other | Conventional Glucose Control, Placebo, Deep anesthesia, Conventional Glucose Control, Placebo, Light anesthesia, Intensive Glucose Control, Placebo, Deep anesthesia, Intensive Glucose Control, placebo, Light anesthesia |
| Anesthesia management -PlaceboDeep anesthesia to maintain BIS about 35 | Other | Conventional Glucose Control, Dexamethasone, Deep anesthesia, Conventional Glucose Control, Placebo, Deep anesthesia, Intensive Glucose Control, Dexamethasone, Deep anesthesia, Intensive Glucose Control, Placebo, Deep anesthesia |
Primary outcome
Major Perioperative Morbidity
Time frame: 30 day after surgery
Our primary outcome was a collapsed composite endpoint (any versus none) defined as the occurrence of at least one of sixteen major complications before hospital discharge, including sepsis, severe surgical site infection, myocardial infarction, heart failure, stroke, unstable ventricular arrhythmias, pulmonary embolism, pneumonia, respiratory failure, dialysis dependent renal failure, large pleural or peritoneal effusions, major bleeding, major wound and surgical site healing complications, vascular graft thrombosis, and 30-day mortality.
1 secondary outcome
1 Year Mortality
Time frame: 1 year after surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37526194Bellon F, Sola I, Gimenez-Perez G, Hernandez M, Metzendorf MI, Rubinat E, Mauricio D. Perioperative glycaemic control for people with diabetes undergoing surgery. Cochrane Database Syst Rev. 2023 Aug 1;8(8):CD007315. doi: 10.1002/14651858.CD007315.pub3.
- Derived from this study: PubMed 26897443Abdelmalak BB, Duncan AE, Bonilla A, Yang D, Parra-Sanchez I, Fergany A, Irefin SA, Sessler DI. The intraoperative glycemic response to intravenous insulin during noncardiac surgery: a subanalysis of the DeLiT randomized trial. J Clin Anesth. 2016 Mar;29:19-29. doi: 10.1016/j.jclinane.2015.10.005. Epub 2016 Feb 2.
- Derived from this study: PubMed 23539236Abdelmalak BB, Bonilla A, Mascha EJ, Maheshwari A, Tang WH, You J, Ramachandran M, Kirkova Y, Clair D, Walsh RM, Kurz A, Sessler DI. Dexamethasone, light anaesthesia, and tight glucose control (DeLiT) randomized controlled trial. Br J Anaesth. 2013 Aug;111(2):209-21. doi: 10.1093/bja/aet050. Epub 2013 Mar 28.
- Derived from this study: PubMed 21598057Abdelmalak B, Maheshwari A, Kovaci B, Mascha EJ, Cywinski JB, Kurz A, Kashyap VS, Sessler DI. Validation of the DeLiT Trial intravenous insulin infusion algorithm for intraoperative glucose control in noncardiac surgery: a randomized controlled trial. Can J Anaesth. 2011 Jul;58(7):606-616. doi: 10.1007/s12630-011-9509-3. Epub 2011 May 20.
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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.
Basem Abdelmalak, MD principal investigator
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dexamethasone Sodium Sulfate, Insulin and anesthesia management in people with Inflammation and Perioperative Morbidity, run by d sessler at 1 site in United States.
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 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: stopped early, as of the sponsor's last update on 25 Apr 2017. 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 United States. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 25 Apr 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Major Perioperative Morbidity (time frame: 30 day after surgery). 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 NCT00995501, which also lists 4 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 25 Apr 2017.