Glucose Control in Open Heart Surgery

Plain-language guide to NCT00370643: phase 1 randomized trial of Insulin (regular human), gum disease (periodontal) & oral health, 98 participants. Who took part, design and what was measured.

Key Facts

Registry ID: NCT00370643
Phase: phase 1
Status: completed
Start: 2002-10
Completion (planned or actual): 2004-11
Participants: 98
Design: randomized, open label (everyone knows who gets what), treatment
Conditions studied: Hyperglycaemia During Perioperative Period; Heart Valve Diseases; Ventricular Dysfunction
Results posted: not yet

What This Study Did, in Plain Language

What Was Tested

The trial (phase 1) is built around Insulin (regular human) for gum disease (periodontal) & oral health.

The registry classes the interventions as drug.

More on the Plan

Hyperglycaemia in the intensive care unit and perioperative period has been accused to be one of the causes of worse clinical outcome.

Their trial had the intention to seek if there is difference setting glucose level in 2 different ones would modifies clinical outcome.

Who Took Part

The registry lists 98 planned participants were the target.

It was open to people of any sex aged from 21 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Adult more than 21 years old. Open heart surgery with cardiopulmonary bypass.

The full record lists 2 inclusion and 6 exclusion criteria; among the exclusions: renal dysfunction; use of inotropic support; neurological dysfunction.

How the Study Was Run

Design: randomized, parallel-group and open-label.

Because people in this Insulin (regular human) study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

The Insulin (regular human) group and the comparison group ran side by side rather than switching.

Everyone knew when Insulin (regular human) was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2002-10 with completion listed for 2004-11.

It ran at 1 site in Brazil.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Duration of intubation. ICU length. Blood transfusion.

It also tracked 6 secondary outcomes, for example Length of surgery, Length of cardiopulmonary bypass, Physical status, EuroSCORE, Parsonnet and Canadian Multicenter index.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Insulin (regular human) in 98 people with gum disease (periodontal) & oral health.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Insulin (regular human) compound page, Gum disease (periodontal) & oral health research.

Our Notes on the Compound

Insulin (regular human): The 51-amino-acid pancreatic hormone that lowers blood glucose; this page covers regular (short-acting) insulin studied in human trials.

Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.