NCT02574156

Brief Summary

The investigators aim to study the impact of a strategy of a intensive glycemic control in patients undergoing cardiac surgery.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Jan 2017

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 8, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 12, 2015

Completed
1.2 years until next milestone

Study Start

First participant enrolled

January 1, 2017

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2018

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2019

Completed
Last Updated

November 4, 2022

Status Verified

October 1, 2022

Enrollment Period

1.6 years

First QC Date

October 8, 2015

Last Update Submit

October 31, 2022

Conditions

Hyperglycemia

Outcome Measures

Primary Outcomes (1)

  • Infection of surgical wound infection

    The primary outcome measure will be assessed according to the American Society of Thoracic Surgeons guidelines

    30 days

Secondary Outcomes (6)

  • Need for reoperation

    30 days

  • Acute renal injury (defined by the KDIGO classification)

    30 days

  • Infection of the bloodstream

    90 days

  • Prolonged mechanical ventilation

    90 days

  • Need for transfusion of blood products

    90 days

  • +1 more secondary outcomes

Study Arms (2)

Conventional Group

EXPERIMENTAL

Patients randomized for Conventional Group will receive insulin infusion of regular insulin (100 UI) in 100 mL of saline in continuous infusion pump for maintenance of blood glucose between 140 mg/dl and 180 mg/dl.

Drug: Insulin

Moderate Group

EXPERIMENTAL

Patients randomized for ModerateGroup will receive insulin infusion of regular insulin (100 UI) in 100 mL of saline in continuous infusion pump for maintenance of blood glucose between 100 mg/dl and 130 mg/dl.

Drug: Insulin

Interventions

InsulinDRUG

All patients will receive insulin. However, the infusion flow will be different according to the group.

Also known as: Glycemic Control
Conventional GroupModerate Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients undergoing heart surgery;
  • Age greater than 18 years;
  • Sign the informed consent form;
  • Capillary blood glucose greater than 200mg/dL ICU admission

You may not qualify if:

  • Admitted for surgical repair of congenital heart defects;
  • Dialytic Chronic renal failure;
  • Participation in other research protocol;
  • Diagnosis of HIV/AIDS;
  • Pregnant.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eduesley Santana Santos

São Paulo, 01307-000, Brazil

Location

Related Publications (8)

  • Macrae D, Grieve R, Allen E, Sadique Z, Morris K, Pappachan J, Parslow R, Tasker RC, Elbourne D; CHiP Investigators. A randomized trial of hyperglycemic control in pediatric intensive care. N Engl J Med. 2014 Jan 9;370(2):107-18. doi: 10.1056/NEJMoa1302564.

    PMID: 24401049RESULT

  • Yates AR, Dyke PC 2nd, Taeed R, Hoffman TM, Hayes J, Feltes TF, Cua CL. Hyperglycemia is a marker for poor outcome in the postoperative pediatric cardiac patient. Pediatr Crit Care Med. 2006 Jul;7(4):351-5. doi: 10.1097/01.PCC.0000227755.96700.98.

    PMID: 16738506RESULT

  • NICE-SUGAR Study Investigators; Finfer S, Chittock DR, Su SY, Blair D, Foster D, Dhingra V, Bellomo R, Cook D, Dodek P, Henderson WR, Hebert PC, Heritier S, Heyland DK, McArthur C, McDonald E, Mitchell I, Myburgh JA, Norton R, Potter J, Robinson BG, Ronco JJ. Intensive versus conventional glucose control in critically ill patients. N Engl J Med. 2009 Mar 26;360(13):1283-97. doi: 10.1056/NEJMoa0810625. Epub 2009 Mar 24.

    PMID: 19318384RESULT

  • Brunkhorst FM, Engel C, Bloos F, Meier-Hellmann A, Ragaller M, Weiler N, Moerer O, Gruendling M, Oppert M, Grond S, Olthoff D, Jaschinski U, John S, Rossaint R, Welte T, Schaefer M, Kern P, Kuhnt E, Kiehntopf M, Hartog C, Natanson C, Loeffler M, Reinhart K; German Competence Network Sepsis (SepNet). Intensive insulin therapy and pentastarch resuscitation in severe sepsis. N Engl J Med. 2008 Jan 10;358(2):125-39. doi: 10.1056/NEJMoa070716.

    PMID: 18184958RESULT

  • Preiser JC, Devos P, Ruiz-Santana S, Melot C, Annane D, Groeneveld J, Iapichino G, Leverve X, Nitenberg G, Singer P, Wernerman J, Joannidis M, Stecher A, Chiolero R. A prospective randomised multi-centre controlled trial on tight glucose control by intensive insulin therapy in adult intensive care units: the Glucontrol study. Intensive Care Med. 2009 Oct;35(10):1738-48. doi: 10.1007/s00134-009-1585-2. Epub 2009 Jul 28.

    PMID: 19636533RESULT

  • Dandona P, Mohanty P, Chaudhuri A, Garg R, Aljada A. Insulin infusion in acute illness. J Clin Invest. 2005 Aug;115(8):2069-72. doi: 10.1172/JCI26045.

    PMID: 16075050RESULT

  • Boyle EM Jr, Pohlman TH, Johnson MC, Verrier ED. Endothelial cell injury in cardiovascular surgery: the systemic inflammatory response. Ann Thorac Surg. 1997 Jan;63(1):277-84. doi: 10.1016/s0003-4975(96)01061-2.

    PMID: 8993292RESULT

  • Shahian DM, O'Brien SM, Filardo G, Ferraris VA, Haan CK, Rich JB, Normand SL, DeLong ER, Shewan CM, Dokholyan RS, Peterson ED, Edwards FH, Anderson RP; Society of Thoracic Surgeons Quality Measurement Task Force. The Society of Thoracic Surgeons 2008 cardiac surgery risk models: part 3--valve plus coronary artery bypass grafting surgery. Ann Thorac Surg. 2009 Jul;88(1 Suppl):S43-62. doi: 10.1016/j.athoracsur.2009.05.055.

    PMID: 19559824RESULT

MeSH Terms

Conditions

Hyperglycemia

Interventions

InsulinGlycemic Control

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

ProinsulinInsulinsPancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and ProteinsTherapeutics

Study Officials

  • Eduesley Santana Santos, Ph.D

    University of Sao Paulo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
RN, Ph.D

Study Record Dates

First Submitted

October 8, 2015

First Posted

October 12, 2015

Study Start

January 1, 2017

Primary Completion

August 1, 2018

Study Completion

April 1, 2019

Last Updated

November 4, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will share

Locations

BR(1)