Control of Hyperglycemia After Cardiac Surgery: CHyCS Trial

What Was Tested

This registered phase 3 trial tested Insulin (regular human).

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

It had two arms (groups): Conventional Group (experimental) and Moderate Group (experimental).

The registry classes the interventions as drug.

More on the Plan

As soon as possible, the patient will be nurtured according to the routine of Surgical ICU for nutrition in the postoperative period of cardiac surgery patient.

Who Took Part

500 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

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

Examples of who could join: Age greater than 18 years;. Sign the informed consent form;.

The full record lists 4 inclusion and 5 exclusion criteria; among the exclusions: dialytic chronic renal failure;; participation in other research protocol;; diagnosis of hiv/aids;.

How the Study Was Run

It was run as a randomized, parallel-group and open-label study.

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.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Nothing was hidden in this open-label Insulin (regular human) study: the participants and staff both knew the treatment.

It started in 2017-01-01 with completion listed for 2018-08-01.

It ran at 1 site in Brazil.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Infection of surgical wound infection (time frame: 30 days).

It also tracked 6 secondary outcomes, for example Need for reoperation, Acute renal injury (defined by the KDIGO classification), Infection of the bloodstream, Prolonged mechanical ventilation, Need for transfusion of blood products and Occurrences of hypoglycemia.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Insulin (regular human) in 500 people.

With 500 participants it is a large trial for this field.

It ended early (terminated); no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Insulin (regular human) compound page, all human trials.