Nicotine Replacement Therapy in the Intensive Care Unit

What Was Tested

In this phase 4 trial, researchers set out to test Therapeutic nicotine (patch, non-peptide).

It had two arms (groups): Nicotine patch (experimental) and Control patch (placebo comparator).

The control product is a look-alike patch compared to the test product, containing no nicotine or other active substances.

The registry classes the interventions as drug and other.

More on the Plan

There are about 1.2 billion smokers in the world, half of whom will die from diseases caused by smoking.

Furthermore, abstinence from the highly addictive tobacco products can lead to withdrawal symptoms.

Retrospective studies found a higher, lower or equal mortality in critically ill patients receiving nicotine replacement therapy compared to patients receiving no nicotine replacement.

Who Took Part

Enrollment: 47 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: Critically ill active smoking patient. Being mechanically ventilated. Start of study product application within 48 hours after ICU admission. Expected to be mechanically ventilated for more than 48 hours after start of application of the study product.

The full record lists 4 inclusion and 17 exclusion criteria; among the exclusions: patient younger than 18 years; patient or next of kin denying research authorization; breastfeeding women.

How the Study Was Run

Design: randomized, parallel-group and quadruple-blind.

The participants were allocated by chance, so the Therapeutic nicotine (patch, non-peptide) group and the comparison group should start out alike.

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

Neither the participants nor the staff measuring them knew who was on Therapeutic nicotine (patch, non-peptide), so expectations could not easily colour the readings.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2012-06 with completion listed for 2016-08.

It ran at 2 sites in Netherlands (2).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: 30-day Mortality (time frame: 30 days). Patient Location Day 30 (time frame: On day 30).

It also tracked 1 secondary outcome, for example 90-day Mortality.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Therapeutic nicotine (patch, non-peptide) in 47 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Therapeutic nicotine (patch, non-peptide) compound page, all human trials.