ClinicalTrials.gg
CompletedNCT00096421Updated Oct 26, 2006

Tight Glycemic Control in Critical Care Patients

A Phase 3 interventional study of Tight control of blood glucose levels and Conventional control of glucose levels in Critical Illness, Hyperglycemia and Insulin Resistance, sponsored by Hospital Pablo Tobón Uribe. Completed at 1 site in Colombia. Open to participants aged 15 Years and older. Per ClinicalTrials.gov, last updated 2006-10-26.

Primary conditionHyperglycemiaRegistry: Critical IllnessReclassifiedWhy we changed it
Registry
Critical Illness — the first condition term the registry derived for this study.
ClinicalTrials.gg
Hyperglycemia
Why
  1. Critical Illness is a broad heading, used only when no more specific condition is named.
  2. The study's listed conditions name Hyperglycemia.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Hospital Pablo Tobón Uribe · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
504
Allocation
Randomized
Ages
15 Years and older
Sex
All
01

Study summary

The purpose of this study is to evaluate the impact of tight control of serum glucose levels with an intensive insulin treatment in patients hospitalized in an intensive care unit with medical and surgical patients.

Read the detailed description

Reduction of morbidity-mortality in critical care patients with tight glycemic control had been proven in surgical patients only.

Study Hypothesis: In critical care patients, medical or surgical, a glucose serum level between 80 - 110 mg/dL means a lower mortality than patients with glucose levels of more than 110 mg/dL.

02

Conditions studied

  • Critical Illness
  • Hyperglycemia
  • Insulin Resistance

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Keywords

  • Critical illness
  • Critical care
  • Hyperglycemia
  • Intensive care
  • Intensive Care Units
  • Insulin resistance
  • Intensive insulin therapy
  • Conventional insulin therapy
03

In context

Hyperglycemia Reclassified

800 studies on the registry are indexed under Hyperglycemia; 115 are open to participants now.

This study's enrollment of 504 is above the median of 50 across 620 interventional studies indexed under Hyperglycemia.

Browse Hyperglycemia studies →

Lead sponsor

Hospital Pablo Tobón Uribe is the lead sponsor of 7 studies on the registry; none are open to participants now.

Compared within Hyperglycemia, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Critical Illness. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
15 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 15 years of age or older,
  • Probability of staying in critical care for more than 48 hours,
  • Agreement with the .

Exclusion criteria

Exclusion Criteria:

  • Pregnancy,
  • Participating in other trials,
  • Diabetic keto-acidosis or diabetic hyperosmolar state,
  • Moribund
  • Do-not-resuscitate orders,
  • Reentry to the critical care unit of the same patient.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
504 participants

Interventions

  • BehavioralTight control of blood glucose levels
  • BehavioralConventional control of glucose levels
06

What researchers measure

Primary outcomes

  1. Mortality in the next 28 days

Secondary outcomes

  1. Mortality during intensive care

  2. Mortality overall in-hospital

  3. Mortality among patients who remained in the intensive care unit for more than five days

  4. Infections incidence in the critical care unit: nosocomial pneumonia, urinary tract infection and catheter related infection

  5. Length of stay in the unit

  6. Days of ventilatory support

  7. Acute renal failure requiring dialysis or hemofiltration

  8. The median number of red-cell transfusions

  9. SOFA score

  10. Critical-illness polyneuropathy

07

Study locations

1 site
  • Hospital Pablo Tobon Uribe
    Medellin, Antioquia, Colombia
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jul 2003 and a completion of Sep 2006. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 9, 2004
First posted
Nov 10, 2004
Start
Jul 2003
Completion
Sep 2006
Last update
Oct 26, 2006
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
No changes since tracking began. The registry record was last updated on Oct 26, 2006, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00096421
Lead sponsor
Hospital Pablo Tobón Uribe
Collaborators
Instituto Colombiano para el Desarrollo de la Ciencia y la Tecnología (COLCIENCIAS)
First posted
Nov 10, 2004
Start date
Jul 2003
Completion
Sep 2006
Last update
Oct 26, 2006

Study contacts

Gisela D De La Rosa, MD
principal investigator · Hospital Pablo Tobon Uribe
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2006. You cannot join it, but the record below documents what was studied.

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