Effect of Age on MortalityNCT06888206
Impact of Age on Mortality in Critically Ill Adult Patients in Nepal- a Single Center Retrospective Study of 5 Years.
An observational study of Effect of Age on Mortality and ICU Mortality, run by Tribhuvan University Teaching Hospital, Institute Of Medicine. at 1 site in Nepal.
Trial summary
Rationale: Age is often considered a strong factor that determines the outcomes in critically ill patients. In a resource limited low middle income country (LMIC) like Nepal, the age factor is often considered when making treatment decisions by family especially when considering limiting treatment modalities. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Effect of Age on Mortality, ICU Mortality, Age
- How many people
- 8,189 participants
- Where
- 1 siteNepal
- Study dates
- 1 Nov 2019to 31 Dec 2024
- How long will I take part?
- 1 Day
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients admitted to the ICUs of Tribhuvan University Teaching Hospital will be enrolled for this registry based retrospective study
Who may be able to join
- Age>18 years Admission to the ICU
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Rationale: Age is often considered a strong factor that determines the outcomes in critically ill patients. In a resource limited low middle income country (LMIC) like Nepal, the age factor is often considered when making treatment decisions by family especially when considering limiting treatment modalities. Whether or not this consideration of age for outcome prediction is appropriate however is a different discussion especially considering the fact that actual data from Nepalese ICUs are missing.
Study Objective: To find the impact of age on mortality in critically ill patients.
Read more
Design: A registry based, retrospective, descriptive study. Sample size: Convenience sampling of all the patients who are admitted to the ICU.
Duration: Retrospective data from the 5-year period between November, 2019 to December, 2024.
Place: Intensive care units (ICUs), Tribhuvan University Teaching Hospital (TUTH).
Interventions: Not applicable Expected results: The study will help determine the mortality of the critically ill adult patients in terms of age.
Read the detailed description
Age is often considered a poor prognostic factor for most disease conditions. However the effect of age on mortality may not be as simple. Few studies have shown contradicting results such that chronological age exerted no effect on mortality. This may be due to the effect of physiological reserve and well being more than the chronological age.
It has to be noted that with improvement in the overall health care along with the increase in the average life expectancy, ICUs all over the world will be facing a lot more of an "aged" population.
This is even more relevant in our context. The average life expectancy at birth in Nepal has significantly gone up from about 65 years in 2000 AD to 70 years in 2021. This can be expected to improve further with improvements in neonatal and child mortality rates, immunization rates, the health care system delivery and reach. With this, the adult care medicine in Nepal should gear up to face older patients with a new set of challenges including increasing frailty, increasing comorbidities, increased requirements of supportive therapy including rehabilitation and nutrition.
As of now age is often considered a significant factor for making health decisions in Nepal. In a resource limited setting in such an LMICs where a majority of the population lack health insurance coverage, health care costs are borne by the family.
This, when added to the general notion that elderly patients have a poor prognosis, may lead to an unfounded decision to limit treatment decisions including withdrawal of treatments from the ICU.
Rationale and Justification of study This study will help to determine the age related mortality of patients admitted to the ICU. As per the knowledge of the authors, no such large scale studies have been published from Nepal.
- Conditions
- Effect of Age on Mortality, ICU Mortality, Age
- Keywords
- Age, Mortality, Intensive care unit, Low-middle income country
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Young adult | Patients admitted to the ICU in the age group less than 24 | |
| Adult | Adults of the age group 25-44 | |
| Middle age | Patients of the age group 45-64 | |
| Older adult | Patients of the age group >65 years |
What is being measured
The primary outcome is the main question the study is designed to answer.
All cause ICU mortality
- To determine the all cause ICU mortality among rates among patients in ICU grouped according to Medical Subject Heading(MeSH)
- Young adult: 19-24 years
- Adult: 25-44 years
- Middle aged: 45-64 years
- Older adult (Senior): >65 years
- To determine the all cause ICU mortality among rates among patients in ICU grouped into decades
- To determine the all cause ICU mortality among rates among patients >65 years in ICU according to WHO classification of elderly
- Young-old: 60-74 years
- Old-old: 75- 84 years
- Oldest-Old: >85 years
Measured: 2019, November to 2024 December
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2025
- Study start1 Nov 2019
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Effect of Age on MortalityStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 8,189 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Tribhuvan University Teaching Hospital, Institute Of Medicine.
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bipin Karki, Tribhuvan University Teaching Hospital, Institute Of Medicine.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06888206
- Sponsor's protocol ID
- 400(6-11)E2- 081/082
- Status last verified
- Mar 2025
- First submitted
- 15 Mar 2025
- Last updated
- 25 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The de-identified patient data may be shared with the statistician for statistical analysis
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Age on Mortality in Critically Ill Adult Patients in Nepal- a Single Center Retrospective Study of 5 Years.
- ClinicalTrials.gov ID
- NCT06888206
- Acronym / sponsor ID
- 400(6-11)E2- 081/082
- Conditions
- Effect of Age on Mortality, ICU Mortality, Age
- Keywords
- Age, Mortality, Intensive care unit, Low-middle income country
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 8,189 participants (actual)
- Lead sponsor
- Tribhuvan University Teaching Hospital, Institute Of Medicine.University, hospital or other
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 21 Mar 2025 (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.
Rationale: Age is often considered a strong factor that determines the outcomes in critically ill patients. In a resource limited low middle income country (LMIC) like Nepal, the age factor is often considered when making treatment decisions by family especially when considering limiting treatment modalities. Whether or not this consideration of age for outcome prediction is appropriate however is a different discussion especially considering the fact that actual data from Nepalese ICUs are missing.
Study Objective: To find the impact of age on mortality in critically ill patients.
Design: A registry based, retrospective, descriptive study. Sample size: Convenience sampling of all the patients who are admitted to the ICU.
Duration: Retrospective data from the 5-year period between November, 2019 to December, 2024.
Place: Intensive care units (ICUs), Tribhuvan University Teaching Hospital (TUTH).
Interventions: Not applicable Expected results: The study will help determine the mortality of the critically ill adult patients in terms of age.
Detailed description
Age is often considered a poor prognostic factor for most disease conditions. However the effect of age on mortality may not be as simple. Few studies have shown contradicting results such that chronological age exerted no effect on mortality. This may be due to the effect of physiological reserve and well being more than the chronological age.
It has to be noted that with improvement in the overall health care along with the increase in the average life expectancy, ICUs all over the world will be facing a lot more of an "aged" population.
This is even more relevant in our context. The average life expectancy at birth in Nepal has significantly gone up from about 65 years in 2000 AD to 70 years in 2021. This can be expected to improve further with improvements in neonatal and child mortality rates, immunization rates, the health care system delivery and reach. With this, the adult care medicine in Nepal should gear up to face older patients with a new set of challenges including increasing frailty, increasing comorbidities, increased requirements of supportive therapy including rehabilitation and nutrition.
As of now age is often considered a significant factor for making health decisions in Nepal. In a resource limited setting in such an LMICs where a majority of the population lack health insurance coverage, health care costs are borne by the family.
This, when added to the general notion that elderly patients have a poor prognosis, may lead to an unfounded decision to limit treatment decisions including withdrawal of treatments from the ICU.
Rationale and Justification of study This study will help to determine the age related mortality of patients admitted to the ICU. As per the knowledge of the authors, no such large scale studies have been published from Nepal.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Young adult | – | –Patients admitted to the ICU in the age group less than 24 |
| Adult | – | –Adults of the age group 25-44 |
| Middle age | – | –Patients of the age group 45-64 |
| Older adult | – | –Patients of the age group >65 years |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients admitted to the ICUs of Tribhuvan University Teaching Hospital will be enrolled for this registry based retrospective study
Key inclusion criteria (1 listed)
- Age>18 years Admission to the ICU
Key exclusion criteria (1 listed)
- None
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
All cause ICU mortality
Time frame: 2019, November to 2024 December
* To determine the all cause ICU mortality among rates among patients in ICU grouped according to Medical Subject Heading(MeSH) * Young adult: 19-24 years * Adult: 25-44 years * Middle aged: 45-64 years * Older adult (Senior): >65 years * To determine the all cause ICU mortality among rates among patients in ICU grouped into decades * To determine the all cause ICU mortality among rates among patients >65 years in ICU according to WHO classification of elderly * Young-old: 60-74 years * Old-old: 75- 84 years * Oldest-Old: >85 years
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 25 Mar 2025.
- Individual participant dataSharing planned: Yes. The de-identified patient data may be shared with the statistician for statistical analysis
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Effect of Age on Mortality and ICU Mortality, run by Tribhuvan University Teaching Hospital, Institute Of Medicine. at 1 site in Nepal.
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 1 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 25 Mar 2025. 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 Nepal. 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?
All cause ICU mortality (time frame: 2019, November to 2024 December). 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 25 Mar 2025.