Sponsor study identifier
observational
116
1 country
1
Study Start
January 14, 2022
Actual (reported)Primary Completion
June 21, 2023
Actual (reported)Study Completion
August 5, 2023
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 5, 2023
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 30, 2021
Actual (reported)January 14, 2022
Actual (reported)January 14, 2022
Actual (reported)June 21, 2023
Actual (reported)August 5, 2023
Actual (reported)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
Gatroesophageal reflux disease-Health-related quality of life score among GERD present patients
12 weeks after ICU discharge
All critically ill adult patients who survived at the time of ICU discharge
Department of Critical Care Medicine, Sanjay Gandhi Postgraduate Institute of Medical Sciences (SGPGIMS)
Lucknow, Uttar Pradesh, 226014, India
Mohan Gurjar, MD, PDCC
Sanjay Gandhi Postgraduate Institute of Medical Sciences (SGPGIMS)
116 participants (actual enrollment reported by the registry).
First Submitted
December 30, 2021
First Posted
January 14, 2022
Study Start
January 14, 2022
Actual (reported)Contact the study team to confirm eligibility.
Primary Completion
June 21, 2023
Actual (reported)Study Completion
August 5, 2023
Actual (reported)Last Updated
August 8, 2023
Record last verified: 2023-08
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Source: ClinicalTrials.gov.
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