CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 66 enrolled
Drug / intervention
Implementation of management pharmacological protocol of constipation +1 moreprocedure
Likely dose
Not stated in record
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Search/NCT04462211
NCT04462211N/ACompleted

Pilot Study of the Preparation and Implementation of a Constipation Bundle & Management Protocol and the Effect of Adherence in Reducing the Incidence of Constipation in Critically Ill Patients of a University Hospital

University of Chile·interventional·Posted Jul 8, 2020·Updated Jun 8, 2021

In Brief

A clinical study evaluating Implementation of management pharmacological protocol of constipation and Implementation of bundle of prevention and non-pharmacological management for Constipation and 2 related conditions. Completed, enrolled 66 participants across 1 site.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesChile
Collaborators--

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedJul 8, 2020
Enrollment StartAug 1, 2019
Primary CompletionFeb 1, 2020
Study CompletionMar 1, 2020
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 6.0 years ago

Interventions

Implementation of management pharmacological protocol of constipationprocedure

first 48 hours: * polyethylene glycol 3350 (about 17 grams) 1 every 8 hours enterally. * Patients who have vomiting and / or gastric residue greater than 500 mL (in a timely measurement every 6 hours) will also be given domperidone 10 mg every 8 hours intravenously. * Patients who have excessive abdominal distension will be administered in addition, levosulpiride 25 mg every 8 hours intravenously. 48 hour evaluation: * Patients who do not have bowel movements will be administered lactulose or sodium phosphate enema. * For patients who do not have a bowel movement, administration of neostigmine intravenously or of naloxone enterally will be evaluated. * Every patient who uses one or more prokinetics will have an electrocardiogram. * Any patient who has bowel movements during management, doses of polyethylene glycol 3350 will be adjusted according to the daily goal of bowel movements, the days of treatment of the prokinetics will be adjusted, for a maximum of 5 consecutive days.

Implementation of bundle of prevention and non-pharmacological managementprocedure

Bundle of prevention: * Start early enteral nutrition. * Optimize and / or decrease opioid doses. * Start early mobilization. Non-pharmacological management bundle * Select laxative and/or prokinetic/s to manage constipation. * Optimize and / or decrease doses of opioids and sedatives. * Start early mobilization. * Pharmacological reconciliation.