NCT04462211: motility

Constipation Bundle/Protocol and the Effect of Adherence in the Incidence of Constipation in Critically Ill Patients

Completed NA Last updated 8 June 2021

What this trial tests

NA trial testing Implementation of management pharmacological protocol of constipation in Constipation in 66 participants. Completed in 1 March 2020.

Timeline

1 August 2019

Primary endpoint
1 February 2020

1 March 2020

Quick facts

Lead sponsor	University of Chile
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	66
Start date	1 August 2019
Primary completion	1 February 2020
Estimated completion	1 March 2020
Sites	1 location across Chile

Drugs / interventions tested

• Implementation of management pharmacological protocol of constipation
• Implementation of bundle of prevention and non-pharmacological management

Conditions studied

• Constipation — all drugs for Constipation →
• Critical Illness — all drugs for Critical Illness →
• Constipation Drug Induced — all drugs for Constipation Drug Induced →

Sponsor

University of Chile

Who can join

18 and older, any sex, with Constipation or Critical Illness. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Gastrointestinal abnormalities are present in more than 80% of critical patients, and their management has taken an important importance in intensive care unit (ICU), since it can largely determine the clinical outcome, costs and long-term prognosis in This group of patients. Only the constipation in the critical patient has been related to the failure of weaning of the mechanical ventilator, an increase in mechanical ventilation time, and with the increase of the stay in the ICU.

In general, most critical health conditions cause a decrease in the motility of the gastrointestinal tract that intrinsically can contribute to constipation. This is explained by the increase in pro-inflammatory cytokines, increased activity of the sympathetic system, the use of vasopressors, high and prolonged doses of opiates, among others, which can reduce gastric emptying and delay motility. These gastrointestinal abnormalities may be associated with an increase in intra-abdominal pressure, reduced nutritional intake, bacterial hyperproliferation in the digestive tract, intestinal mucosal injury and bacterial translocation through the injured and / or inflamed mucosa. In addition, patients who experience constipation often have gastroparesis and paresis of the ileum, conditions that hinder the progression of nutritional support enterally and worsen the patient's clinical picture.

In spite of being quite common in the ICU, the impact is not known in depth, which implies that these alterations are usually not prevented and on the other hand when treating their pharmacological and non-pharmacological management is highly variable because, for a On the other hand, staff turnover (intensivist physician) and on the other hand because there are no protocols that reduce these problems.

To provide comprehensive care in critical patient units, according to the best available evidence in order to reduce the variation in daily care, clinical guidelines and protocols are applied to manage the various specific problems that affect this group. of patients One way to address the complexity of these problems is through the implementation of care packages, which have taken relevance in the prevention of characteristic events of high mortality and morbidity. It is in this scenario, where the clinical pharmacist plays an important role in the development of protocols, packages and their compliance. The clinical pharmacist is dedicated to the review of the therapy of each patient, through pharmacological conciliation actions with the attending physician, actively participating in the daily round of the multidisciplinary team and at the same time developing "professional support activities" that include , reviews of adverse events associated with medications, education, auditing, research, development of guidelines and institutional protocols for the use of effective and safe medications, with the objective of reducing mortality and its associated costs, thus improving the quality of the Attention.

Given the importance of the problem, it is that this work proposes that the implementation and active dissemination of a constipation bundle/protocol guided by a clinical pharmacist ensures adherence to the strategy in the treatment team and a decrease in the incidence of constipation in the critical patient of the ICU of a university hospital. To fulfill this objective, a quasi-experimental study was designed in which the first stage will be diagnostic observational and a second part of the interventional type, in order to evaluate the effect of adherence to the bundle/protocol on the incidence of constipation in critically ill patients admitted to a ICU of a university hospital for a period of 6 months.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.