Clinical trial NCT05193266: Gastroesophageal Reflux Disease (GERD) Among ICU Survivors
Official title: Gastroesophageal Reflux Disease and Its Health-related Quality of Life Among ICU Survivors
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastroesophageal Reflux Disease
Critically Ill
Keywords: Gatroesophageal reflux disease
Critically ill
Health-related quality of life
Outcome
Survivors
Intensive care unit
Lead sponsor: Sanjay Gandhi Postgraduate Institute of Medical Sciences
Sponsor class: OTHER_GOV
First posted: 2022-01-14
Enrollment: 116
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All critically ill adult patients who survived at the time of ICU discharge

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Prevalence of Gatroesophageal reflux disease (GERD) among ICU survivors
timeFrame: 12 weeks after ICU discharge
Secondary outcomes:
measure: Gatroesophageal reflux disease-Health-related quality of life score among GERD present patients
timeFrame: 12 weeks after ICU discharge
Other outcomes:
Locations:
city: Lucknow
country: India
facility: Department of Critical Care Medicine, Sanjay Gandhi Postgraduate Institute of Medical Sciences (SGPGIMS)
state: UP
Study officials:
affiliation: Sanjay Gandhi Postgraduate Institute of Medical Sciences (SGPGIMS)
name: Mohan Gurjar, MD, PDCC
role: PRINCIPAL_INVESTIGATOR
References: