NCT00282594

Brief Summary

We sought to determine if there is a benefit to using an insulin drip to control hyperglycemia in the surgical critical care unit for patients who undergo general and vascular surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
317

participants targeted

Target at P50-P75 for not_applicable sepsis

Timeline
Completed

Started Jul 2003

Typical duration for not_applicable sepsis

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

July 1, 2003

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2005

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 26, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 27, 2006

Completed
Last Updated

January 27, 2006

Status Verified

November 1, 2005

First QC Date

January 26, 2006

Last Update Submit

January 26, 2006

Conditions

SepsisRespiratory FailureRenal FailureSurgical Site Infection

Keywords

Intensive Insulin TherapyGeneral SurgicalVascular SurgicalTight Glycemic Control

Outcome Measures

Primary Outcomes (1)

  • Mortality

Secondary Outcomes (5)

  • Length of ICU Stay

  • Ventilatory Requirement

  • Vasopressor Support

  • Incidence of Renal Failure

  • Incidence of Wound Infection

Interventions

Novolin R (human recombinant Insulin)DRUG

Eligibility Criteria

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

You may not qualify if:

  • Under age 18

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Genesys Regional Medical Center

Grand Blanc, Michigan, 48439, United States

Location

Related Publications (1)

  • van den Berghe G, Wouters P, Weekers F, Verwaest C, Bruyninckx F, Schetz M, Vlasselaers D, Ferdinande P, Lauwers P, Bouillon R. Intensive insulin therapy in critically ill patients. N Engl J Med. 2001 Nov 8;345(19):1359-67. doi: 10.1056/NEJMoa011300.

    PMID: 11794168BACKGROUND

MeSH Terms

Conditions

SepsisRespiratory InsufficiencyRenal InsufficiencySurgical Wound Infection

Interventions

Insulin

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsRespiration DisordersRespiratory Tract DiseasesKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesWound InfectionPostoperative Complications

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Michael Kia, DO

    Ascension Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 26, 2006

First Posted

January 27, 2006

Study Start

July 1, 2003

Study Completion

October 1, 2005

Last Updated

January 27, 2006

Record last verified: 2005-11

Locations

US(1)