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

NCT04462211 | Completed

• 1 other identifier: OAIC1055/19
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Constipation; Critical Illness; Constipation Drug Induced

Outcome Measures

Primary Outcomes (1)

• Adherence to protocol / bundle implementation.

  The adherence for the protocol and for the bundle will be evaluated by being separated. Both will be evaluated by dichotomous evaluation (is adherent or not adherent). It is adherent for the bundle only if all the interventions for the bundle are fulfilled, likewise, it is adherent for the protocol if all the interventions for the protocol are fulfilled.

  1 mounth

Secondary Outcomes (3)

• Difference in incidence of constipation between observational period group and protocol / bundle implementation period group.

  1 mounths.

• Intolerance to nutritional.

  1 mounths

• Liquid deposition.

  1 mounths.

Study Arms (1)

Management pharmacological protocol and bundle's

EXPERIMENTAL

The elaboration of the protocol according to the evidence-based approach, updated evidence found from both search engines such as MEDLINE, EMBASE, Cochrane Library, OVID and ScIELO will be used through the research question using the PICO method (Patient interest, Intervention, Comparation and Outcome). the ready-made protocol will be adjusted to the pharmacological options that are available in the hospital.

Procedure: Implementation of management pharmacological protocol of constipation; Procedure: Implementation of bundle of prevention and non-pharmacological management

Interventions

Implementation of management pharmacological protocol of constipation PROCEDURE

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.

Management pharmacological protocol and bundle's

Implementation of bundle of prevention and non-pharmacological management PROCEDURE

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.

Management pharmacological protocol and bundle's

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient admitted to the intensivo care unit.
• Hospitalization equal to or greater than 3 days.

You may not qualify if:

• Patient admitted after surgery for resection of the digestive tract.
• Patient with exclusive parenteral nutrition.
• Patient with total intestinal obstruction / ileus, documented during the stay at UPC.
• Patients admitted exclusively for "isolation measures".

Sponsors & Collaborators

• University of Chile: lead

Study Sites (1)

Hospital Clínico Universidad de Chile

Santiago, International, 6677, Chile

Location

Related Publications (16)

• Reintam Blaser A, Malbrain ML, Starkopf J, Fruhwald S, Jakob SM, De Waele J, Braun JP, Poeze M, Spies C. Gastrointestinal function in intensive care patients: terminology, definitions and management. Recommendations of the ESICM Working Group on Abdominal Problems. Intensive Care Med. 2012 Mar;38(3):384-94. doi: 10.1007/s00134-011-2459-y. Epub 2012 Feb 7.

  PMID: 22310869 BACKGROUND

• Rohm KD, Boldt J, Piper SN. Motility disorders in the ICU: recent therapeutic options and clinical practice. Curr Opin Clin Nutr Metab Care. 2009 Mar;12(2):161-7. doi: 10.1097/MCO.0b013e32832182c4.

  PMID: 19202387 BACKGROUND

• Btaiche IF, Chan LN, Pleva M, Kraft MD. Critical illness, gastrointestinal complications, and medication therapy during enteral feeding in critically ill adult patients. Nutr Clin Pract. 2010 Feb;25(1):32-49. doi: 10.1177/0884533609357565.

  PMID: 20130156 BACKGROUND

• Gacouin A, Camus C, Gros A, Isslame S, Marque S, Lavoue S, Chimot L, Donnio PY, Le Tulzo Y. Constipation in long-term ventilated patients: associated factors and impact on intensive care unit outcomes. Crit Care Med. 2010 Oct;38(10):1933-8. doi: 10.1097/CCM.0b013e3181eb9236.

  PMID: 20639749 BACKGROUND

• Prat D, Messika J, Millereux M, Gouezel C, Hamzaoui O, Demars N, Jacobs F, Trouiller P, Ricard JD, Sztrymf B. Constipation in critical care patients: both timing and duration matter. Eur J Gastroenterol Hepatol. 2018 Sep;30(9):1003-1008. doi: 10.1097/MEG.0000000000001165.

  PMID: 29794547 BACKGROUND

• Prat D, Messika J, Avenel A, Jacobs F, Fichet J, Lemeur M, Ricard JD, Sztrymf B. Constipation incidence and impact in medical critical care patients: importance of the definition criterion. Eur J Gastroenterol Hepatol. 2016 Mar;28(3):290-6. doi: 10.1097/MEG.0000000000000543.

  PMID: 26709885 BACKGROUND

• Taylor RW. Gut Motility Issues in Critical Illness. Crit Care Clin. 2016 Apr;32(2):191-201. doi: 10.1016/j.ccc.2015.11.003. Epub 2016 Feb 18.

  PMID: 27016161 BACKGROUND

• Ukleja A. Altered GI motility in critically Ill patients: current understanding of pathophysiology, clinical impact, and diagnostic approach. Nutr Clin Pract. 2010 Feb;25(1):16-25. doi: 10.1177/0884533609357568.

  PMID: 20130154 BACKGROUND

• Fruhwald S, Holzer P, Metzler H. Intestinal motility disturbances in intensive care patients pathogenesis and clinical impact. Intensive Care Med. 2007 Jan;33(1):36-44. doi: 10.1007/s00134-006-0452-7. Epub 2006 Nov 18.

  PMID: 17115132 BACKGROUND

• Mostafa SM, Bhandari S, Ritchie G, Gratton N, Wenstone R. Constipation and its implications in the critically ill patient. Br J Anaesth. 2003 Dec;91(6):815-9. doi: 10.1093/bja/aeg275.

  PMID: 14633751 BACKGROUND

• Nassar AP Jr, da Silva FM, de Cleva R. Constipation in intensive care unit: incidence and risk factors. J Crit Care. 2009 Dec;24(4):630.e9-12. doi: 10.1016/j.jcrc.2009.03.007. Epub 2009 Jul 9.

  PMID: 19592200 BACKGROUND

• Patanwala AE, Abarca J, Huckleberry Y, Erstad BL. Pharmacologic management of constipation in the critically ill patient. Pharmacotherapy. 2006 Jul;26(7):896-902. doi: 10.1592/phco.26.7.896.

  PMID: 16803421 BACKGROUND

• de Azevedo RP, Machado FR. Constipation in critically ill patients: much more than we imagine. Rev Bras Ter Intensiva. 2013 Apr-Jun;25(2):73-4. doi: 10.5935/0103-507X.20130014. No abstract available.

  PMID: 23917968 BACKGROUND

• Farmer AD, Holt CB, Downes TJ, Ruggeri E, Del Vecchio S, De Giorgio R. Pathophysiology, diagnosis, and management of opioid-induced constipation. Lancet Gastroenterol Hepatol. 2018 Mar;3(3):203-212. doi: 10.1016/S2468-1253(18)30008-6.

  PMID: 29870734 BACKGROUND

• McPeake J, Gilmour H, MacIntosh G. The implementation of a bowel management protocol in an adult intensive care unit. Nurs Crit Care. 2011 Sep-Oct;16(5):235-42. doi: 10.1111/j.1478-5153.2011.00451.x.

  PMID: 21824228 BACKGROUND

• Borgert M, Binnekade J, Paulus F, Goossens A, Dongelmans D. A flowchart for building evidence-based care bundles in intensive care: based on a systematic review. Int J Qual Health Care. 2017 Apr 1;29(2):163-175. doi: 10.1093/intqhc/mzx009.

  PMID: 28453823 BACKGROUND

MeSH Terms

Conditions

Constipation; Critical Illness

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Disease Attributes; Pathologic Processes

Study Officials

• José Ignacio JI Farías, Pharmacist

  University of Chile

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associated Professor

Study Record Dates

• First Submitted: December 19, 2019
• First Posted: July 8, 2020
• Study Start: August 1, 2019
• Primary Completion: February 1, 2020
• Study Completion: March 1, 2020
• Last Updated: June 8, 2021

Record last verified: 2021-06

Locations

CL (1)