Gastroesophageal Reflux DiseaseNCT05193266
Gastroesophageal Reflux Disease (GERD) Among ICU Survivors
An observational study of Gastroesophageal Reflux Disease and Critically Ill, run by Sanjay Gandhi Postgraduate Institute of Medical Sciences at 1 site in India.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastroesophageal Reflux Disease, Critically Ill
- How many people
- 116 participants
- Where
- 1 siteIndia
- Study dates
- 14 Jan 2022to 5 Aug 2023
- How long will I take part?
- 12 Weeks
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All critically ill adult patients who survived at the time of ICU discharge
Who may be able to join
- Adult patients (>18 years) who survived at the time of ICU discharge
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
India1 site
Department of Critical Care Medicine, Sanjay Gandhi Postgraduate Institute of Medical Sciences (SGPGIMS)
Lucknow, Uttar Pradesh, 226014
About this study
Official title: Gastroesophageal Reflux Disease and Its Health-related Quality of Life Among ICU Survivors
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.
Read the 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.
- Conditions
- Gastroesophageal Reflux Disease, Critically Ill
- Keywords
- Gatroesophageal reflux disease, Critically ill, Health-related quality of life, Outcome, Survivors, Intensive care unit
- Medical subject headings
- Gastroesophageal Reflux, Critical Illness
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of Gatroesophageal reflux disease (GERD) among ICU survivors
Percentage of ICU survivors among whom Gatroesophageal reflux disease (GERD) present
Measured: 12 weeks after ICU discharge
Secondary outcomes (1)
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.
Measured: 12 weeks after ICU discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2022
- Study start14 Jan 2022
- Primary completion21 Jun 2023
- Study completion5 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastroesophageal Reflux DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 116 participants (actual)
- Target duration
- 12 Weeks
Sponsor and investigators
- Lead sponsor
- Sanjay Gandhi Postgraduate Institute of Medical Sciences
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Mohan Gurjar, Sanjay Gandhi Postgraduate Institute of Medical Sciences
- Investigators
- Mohan Gurjar, MD, PDCC, Principal investigator, Sanjay Gandhi Postgraduate Institute of Medical Sciences (SGPGIMS)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05193266
- Sponsor's protocol ID
- 2021-265-DM-EXP-43
- Status last verified
- Aug 2023
- First submitted
- 30 Dec 2021
- Last updated
- 8 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gastroesophageal Reflux Disease and Its Health-related Quality of Life Among ICU Survivors
- ClinicalTrials.gov ID
- NCT05193266
- Acronym / sponsor ID
- 2021-265-DM-EXP-43
- Conditions
- Gastroesophageal Reflux Disease, Critically Ill
- Keywords
- Gatroesophageal reflux disease, Critically ill, Health-related quality of life, Outcome, Survivors, Intensive care unit
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- Sanjay Gandhi Postgraduate Institute of Medical SciencesOther government
- Study start
- 14 Jan 2022 (actual)
- Primary completion
- 21 Jun 2023 (actual)
- Study completion
- 5 Aug 2023 (actual)
- First posted
- 14 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Weeks
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All critically ill adult patients who survived at the time of ICU discharge
Key inclusion criteria (1 listed)
- Adult patients (>18 years) who survived at the time of ICU discharge
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prevalence of Gatroesophageal reflux disease (GERD) among ICU survivors
Time frame: 12 weeks after ICU discharge
Percentage of ICU survivors among whom Gatroesophageal reflux disease (GERD) present
1 secondary outcome
Gatroesophageal reflux disease-Health-related quality of life score among GERD present patients
Time frame: 12 weeks after ICU discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohan Gurjar, MD, PDCC principal investigator
Sanjay Gandhi Postgraduate Institute of Medical Sciences (SGPGIMS)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastroesophageal Reflux Disease and Critically Ill, run by Sanjay Gandhi Postgraduate Institute of Medical Sciences at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of Gatroesophageal reflux disease (GERD) among ICU survivors (time frame: 12 weeks after ICU discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2023.