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))

NCT00995501 | Terminated Results DMC

• 1 other identifier: 07-010
• Study Type: interventional
• Target: 381
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Inflammation; Perioperative Morbidity

Keywords

steroid administration; tight glucose control; light anesthesiReducing inflammatory response to surgical stress; a

Outcome Measures

Primary Outcomes (1)

• 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.

  30 day after surgery

Secondary Outcomes (1)

• 1 Year Mortality

  1 year after surgery

Study Arms (8)

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

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

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

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

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

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

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

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

Other: Dexamethasone - placebo; Other: Insulin - Placebo; Other: Anesthesia management -Placebo

Interventions

Dexamethasone Sodium Sulfate DRUG

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

Intensive Glucose Control, Dexamethasone, Deep anesthesia; Intensive Glucose Control, Dexamethasone, light anesthesia; Intensive Glucose Control, Placebo, Deep anesthesia; Intensive Glucose Control, placebo, Light anesthesia

Insulin DRUG

Insulin to maintain blood glucose 80-110 mg/dl.

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 management DRUG

Light anesthesia to maintain BIS about 55

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 - placebo OTHER

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

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 - Placebo OTHER

Insulin to maintain blood glucose 180-200 mg/dl.

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 -Placebo OTHER

Deep anesthesia to maintain BIS about 35

Conventional Glucose Control, Dexamethasone, Deep anesthesia; Conventional Glucose Control, Placebo, Deep anesthesia; Intensive Glucose Control, Dexamethasone, Deep anesthesia; Intensive Glucose Control, Placebo, Deep anesthesia

Eligibility Criteria

• Age: 40 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥40 years old.
• Major non-cardiac surgical procedures scheduled to take ≥ two hours done under general anesthesia.
• Written informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• d sessler: lead

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Related Publications (4)

• 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.

  PMID: 37526194 DERIVED

• Abdelmalak 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.

  PMID: 26897443 DERIVED

• Abdelmalak 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.

  PMID: 23539236 DERIVED

• Abdelmalak 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.

  PMID: 21598057 DERIVED

MeSH Terms

Conditions

Inflammation

Interventions

dexamethasone sulfate ester; Insulin

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Proinsulin; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Daniel Sessler, MD
• Organization: Cleveland clinic

sesseld@ccf.org

216-445-4900

Study Officials

• Basem Abdelmalak, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: October 14, 2009
• First Posted: October 15, 2009
• Study Start: January 1, 2007
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: April 25, 2017
• Results First Posted: April 25, 2017

Record last verified: 2017-03

Locations

US (1)