Gastroesophageal Reflux Disease (GERD) Among ICU Survivors

Gastroesophageal Reflux Disease Clinical Trial

Official title:

Gastroesophageal Reflux Disease and Its Health-related Quality of Life Among ICU Survivors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05193266
• Other study ID #: 2021-265-DM-EXP-43
• Status: Completed
• Start date: January 14, 2022
• Est. completion date: August 5, 2023

Study information

• Verified date: August 2023
• Source: Sanjay Gandhi Postgraduate Institute of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Description:

During study period, all patients who survived at the time of ICU discharge will be considered as per inclusion and exclusion criteria. All eligible participants will be screened for the presence of GERD. If GERD present, participants will be followed for their symptoms after 6 week of the ICU discharge. Participant who did not having GERD at the time of ICU discharge will also be followed for the presence of GERD symptoms at 6 weeks after ICU discharge, if participant develop GERD symptoms then they will be followed up again for next 6 weeks. In participants who had GERD symptoms, HRQL score will be collected including 6-week follow up, after obtaining the informed written consent.

Demographic and clinical characteristics of all eligible participants will be collected on structured proforma. ICU prognostication scores, i.e., Acute Physiologic and Chronic Health Evaluation (APACHE) II score and Sequential Organ Dysfunction Assessment (SOFA) will be noted. All relevant and possible risk factors during ICU stay will also be collected. Participants with GERD, GERD-HRQL score will be collected, including 6-week follow-up.

At the time of ICU discharge, participant will be asked for the preference for the way of communication during follow-up with the option of pre-stamped envelope for postal with questionnaire. Participants will be handed over these envelopes with mention of pre-defined follow-up date for that particular patient. In case participant has plan for SGPGIMS visit for his/her pre-scheduled follow-up with any specialty, then data for present study will be collected in person.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 116
• Est. completion date: August 5, 2023
• Est. primary completion date: June 21, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Critical Illness
• Critically Ill
• Esophagitis, Peptic
• Gastroesophageal Reflux
• Gastroesophageal Reflux Disease

Locations

Country	Name	City	State
India	Department of Critical Care Medicine, Sanjay Gandhi Postgraduate Institute of Medical Sciences (SGPGIMS)	Lucknow	UP

Sponsors (1)

Lead Sponsor	Collaborator
Sanjay Gandhi Postgraduate Institute of Medical Sciences

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Gatroesophageal reflux disease-Health-related quality of life score among GERD present patients	Gatroesophageal reflux disease-Health-related quality of life score will be measured two times (6 weeks apart). The minimum score is 0 and maximum score is 50. Higher score means worse outcome.	12 weeks after ICU discharge