Gastroesophageal Reflux Disease (GERD) Among ICU Survivors

NCT05193266 | Completed

• 1 other identifier: 2021-265-DM-EXP-43
• Study Type: observational
• Target: 116
• Locations: 1 country
• Sites: 1

Brief Summary

Gastro-esophageal reflux disease (GERD) is a condition characterized by reflux of stomach contents causing troublesome symptoms and complications. Typical symptoms include heart burn (a retrosternal burning sensation), regurgitation (perception of flow of refluxed stomach content into the mouth or hypopharynx) and chest pain. As per recently published global guidelines (2017) by World Gastroenterology Organisation (WGO), the presence of heartburn and/or regurgitation symptoms 2 or more times a week is suggestive of GERD. Global burden of GERD in general population is approximately 1.03 billion, the prevalence of GERD varies geographically, with the highest prevalence of 19.55% in North America while in Asia, the estimated rate is 12.92%. However the data regarding the prevalence of GERD in intensive care unit (ICU) population is not yet established; which is expected higher after recovery from their current acute illness. In a healthy individual, several factors contribute to the prevention of reflux and to minimizing esophageal acid exposure: lower esophageal sphincter (LES) pressure, the diaphragmatic crura, gravity, esophageal peristalsis, salivary bicarbonate and the integrity of esophageal epithelium. But in critically ill these factors are compromised leading to high incidence of GERD. Interventions commonly used in managing critically ill patients such as sedation, presence of an endotracheal tube, mechanical ventilation, enteral tube feedings, positioning, and medications, along with specific patient characteristics and comorbid conditions contribute to an increased risk for GERD in this population. GERD results in various symptoms which has impact on quality of life. Various reliable and validated generic and disease specific instruments are available to measure symptom severity of the disease. In the present study, among GERD patients, commonly and freely available GERD-Health-related quality of life (GERD-HRQL) score will be used which is a disease-specific instrument. This observational study will screen and enroll adult patients who survived at the time of ICU discharge.

Conditions

Gastroesophageal Reflux Disease; Critically Ill

Keywords

Gatroesophageal reflux disease; Critically ill; Health-related quality of life; Outcome; Survivors; Intensive care unit

Outcome Measures

Primary Outcomes (1)

• Prevalence of Gatroesophageal reflux disease (GERD) among ICU survivors

  Percentage of ICU survivors among whom Gatroesophageal reflux disease (GERD) present

  12 weeks after ICU discharge

Secondary Outcomes (1)

• Gatroesophageal reflux disease-Health-related quality of life score among GERD present patients

  12 weeks after ICU discharge

Eligibility Criteria

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

Study Population

All critically ill adult patients who survived at the time of ICU discharge

You may qualify if:

• Adult patients (\>18 years) who survived at the time of ICU discharge

You may not qualify if:

• ICU stay \<96 hours
• At the time of ICU discharge GCS \<15
• Presence of open abdomen (post surgery)
• Presence of feeding tube at the time of ICU discharge
• Presence of abdominal drain or PEG tube at the time of ICU discharge
• Presence of tracheostomy tube at the time of ICU discharge
• Patient who do not provide written consent
• Pregnancy

Sponsors & Collaborators

• Sanjay Gandhi Postgraduate Institute of Medical Sciences: lead

Study Sites (1)

Department of Critical Care Medicine, Sanjay Gandhi Postgraduate Institute of Medical Sciences (SGPGIMS)

Lucknow, Uttar Pradesh, 226014, India

Location

MeSH Terms

Conditions

Gastroesophageal Reflux; Critical Illness

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Mohan Gurjar, MD, PDCC

  Sanjay Gandhi Postgraduate Institute of Medical Sciences (SGPGIMS)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Weeks
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Critical Care Medicine

Study Record Dates

• First Submitted: December 30, 2021
• First Posted: January 14, 2022
• Study Start: January 14, 2022
• Primary Completion: June 21, 2023
• Study Completion: August 5, 2023
• Last Updated: August 8, 2023

Record last verified: 2023-08

Locations

IN (1)