ARDSNCT02871063
Effect of Altitude on the Evolution of Acute Respiratory Distress Syndrome
An observational study of ARDS and Hypoxia, Altitude, run by Guillermo Ortiz Ruiz.
Trial summary
The purpose of this piece of research is to assess the effect of altitude on the clinical evolution of ARDS. For this purpose, patients who live and receive care at sea level are compared with those who live and receive care at high altitudes. Read more about this study
- Who is it for?
- Ages 16 to 90 years
- Conditions the study is for
- ARDS, Hypoxia, Altitude, Altitude Sickness/Epidemiology
- How many people
- 170 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2016to 1 Oct 2016
- How long will I take part?
- 2 Years
- 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 to 90 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: ARDS patients diagnosed at altitudes greater than 1500 meters above sea level and those of cases diagnosed at altitudes below 1500 meters above sea level
Who may be able to join
- Berlin definition of ARDS
- Pa02/FiO2 ≤ 300 (not corrected for altitude)
- Invasive mechanical ventilation
- Age >16 years
- Informed consent
- The patient stayed at the same altitude for at least 40 days prior to ICUadmission
Who cannot join
- Pregnancy
- Under 16 years
- Not accept informed consent
About this study
The purpose of this piece of research is to assess the effect of altitude on the clinical evolution of ARDS. For this purpose, patients who live and receive care at sea level are compared with those who live and receive care at high altitudes. For reasons of convenience, a cut-point of 1500 meters above sea level was chosen. In addition to this, it will be sought to assess whether adjusting the cut-points for the severity categories of ARDS improves the ability to predict some adverse events, by comparison with unadjusted cut-points. The results of this research will probably be disruptive, and will provide the first information yet about the effect of altitude on ARDS; they will therefore be of great interest for the international scientific community and for the direct care of patients. A high bibliometric impact is to be expected.
Read the detailed description
HYPOTHESIS
Physiological adaptations generated by living at high altitude modify the clinical evolution of ARDS.
OBJECTIVE
To describe the main clinical and developmental characteristics of ARDS diagnosed at altitudes greater than 1500 meters above sea level.
To compare the main clinical and developmental characteristics of ARDS diagnosed at altitudes greater than 1500 meters above sea level with those of cases diagnosed at altitudes below 1500 meters above sea level.
METHODOLOGY
Main events:
Incidence of ARDS
Mortality of ARDS
Duration of mechanical ventilation and length of ICU stay of patients with ARDS Sequelae found 1 year and 3 years after diagnosis of ARDS
Secondary events
Recognition of ARDS by clinician
Modes of mechanical ventilation
Use of adjuvant therapies
Design: observational, prospective, cohort, multicenter, international study
Recruitment period: July 18, 2.016 - August 18, 2.016
General Procedure
The general organization chart of the study implies the participation of 3 lead researchers, at least 1 researcher/coordinator per country, and main researchers of each service.
For the selection of participating services, a general invitation will be sent to all South American ICUs located at altitudes greater than 1500 meters above sea level, as well as a representative group of ICUs located below 1500 meters above sea level.
The 2 cohorts (altitude and sea level) will be generated afterwards; the size of each cohort will be determined by convenience.
For the selection of each participating service, the exploratory form (appendix 1) will be sent beforehand, in order to gain knowledge of its characteristics and possibilities; if the center meets the criteria, it will be enrolled and the rest of the documents (research protocols, appendices 2 and 3) will be sent to it.
Once the participating services are defined, coordination videoconferences will be held before initiation of the study; an e-mail address will be set up for general coordination. All questions will be answered in less than 24 hours.
The data will be collected in an Excel spreadsheet that will be sent to the coordinator of each country, and he will distribute it to the main researcher of each participating center. The information will be afterwards submitted to the general coordinators via the reverse pathway. All information will be sent by e-mail; in order to maintain confidentiality, the spreadsheets will be encrypted. The opening codes will be known only by the researchers responsible for each service, for each country, and by the lead researchers of the study. The data will be included by the main researcher of each center, under supervision of the coordinator of each country.
Day 1 will be the day of admission to ICU with an unadjusted Pa02/Fi02 less than 300, regardless of the day the patient was admitted to hospital or to ICU.
The protocol implies the gathering of basic data (appendix 3), that will be further obtained when the patients meets the criterion of Pa02/Fi02 less than 300. Gathering of data ends 28 days after day 1 (IT MAY NOT CORRESPOND TO DAY 28 AFTER ADMISSION TO ICU); afterwards, data such as date of extubation, of discharge from ICU and from hospital, and condition upon discharge from hospital will be gathered.
Clinical and analytic data will be gathered on admission, and afterwards at the same hour of the morning, while the patient continues under invasive mechanical ventilation.
Diagnosis of ARDS is made by two procedures: (A) automatic, which will consist of individually picking each variable pertaining to the definition, and afterwards, by way of a computer algorithm, defining whether the patient complies with the Berlin definition; (B) clinical, the attending physician will be asked daily, since the moment when PaO2/Fi02<300, what the reason for hypoxemia is. Both diagnoses will be independent and double-blinded. The ratio of concordance will be calculated afterwards.
Operational definitions:
ARDS: Berlin definition.
Days free of mechanical ventilation are the number of days in which no invasive mechanical ventilation is required, from disconnection to day 28. If the patient dies, 0 days free of mechanical ventilation will be considered.
Driving pressure s the plateau pressure minus PEEP.
Incidence is the number of patients diagnosed with ARDS divided by the number of patients who required invasive mechanical ventilation over the study period.
Number of patients with ARDS per bed of the service is the number of patients diagnosed with ARDS divided by the number of beds suitable for mechanical ventilation available over the study period.
Long-term follow-up (1 and 3 years) will be carried out by the central coordination team via e-mail or, occasionally, by telephone.
Finally, a single database will be generated, with which the final report will be done.
All patients with incomplete data will be excluded from the analysis.
Statistical analysis:
In order to fulfill objective 1, a descriptive epidemiological analysis of the primary and secondary events gathered in patients diagnosed with ARDS according to the Berlin definition.
In order to fulfill objective 2, a comparison is made between the proportion of primary and secondary events between the altitude cohort and the sea-level cohort. Categorical variables are presented as number of cases and percentage, continuous variables are presented as median and percentiles 25-75. Categorical variables are compared by the chi-2 continuous variables are compared by Mann-Whitney or Kruskal-Wallis non-parametric tests.
In order to fulfill objective 3, ROC curves will be made for each event, taking into consideration the unadjusted and altitude-adjusted Berlin definition as dependent variable.
The final data report will be done following the recommendations of the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement guidelines for observational cohort studies.
The whole statistical analysis will be made with the free R program (http://www.R-project.org). All P values will be two-tail P values, considering a <0.05 level of signification.
ACCESSIBILITY OF DATA
The data will be accessible to any researcher upon written request to the Latin American Network of High-Altitude Intensive Care Medicine (RELAMI).
The request must be written in Spanish and include:
justification for using the data
commitment to using the data for exclusively scientific purposes (explicitly stating that they will not be used for economic purposes)
commitment to publishing the data in a pubmed indexed journal within a one-year period
proof of experience and background in the field of clinical research adhesion to the code of ethics
RELAMI will analyze the request and decide within a 60-day period from receipt of the request. If the response is positive, the data will be sent anonymized; if it is negative, the reasons will be explained.
ECONOMIC ASPECTS
This study does not have sponsors. No researcher will receive economic compensation or any other type of reward for participating.
ETHICAL ASPECTS
This study will be carried out in accordance with the ethical principles established by the International Conference on Harmonization, guidelines for Good Clinical Practice (GCP), which stem from the Helsinki Declaration and applicable regulation norms.
This study is considered to be of insignificant low risk, since it is an observational, non-interventional study, and the data are gathered without identification. Each participating ICU will process the pertaining institutional approvals, including a renunciation of ethical revision.
Recorded dispensation of each participant for gathering clinical data without identification will be sought as part of routine clinical care.
DATA MANAGEMENT AND DISSEMINATION OF RESULTS
The lead researchers and the Coordination Center will act as guardians of the data. Reports of progress and final reports will be presented opportunely in national and international conferences, giving priority to presentation during annual conferences in Latin America.
The results of the study will be published in indexed scientific journals, preferably of the first decile.
Only aggregated and disidentified data will be publicly presented.
- Conditions
- ARDS, Hypoxia, Altitude, Altitude Sickness/Epidemiology
- Medical subject headings
- Altitude Sickness
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 |
|---|---|---|
| High altitude ARDS | ARDS diagnosed at altitudes greater than 1500 meters above sea level | |
| Sea level ARDS | ARDS diagnosed at altitudes below 1500 meters above sea level |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Acute respiratory distress syndrome (ARDS)
Measured: 1 month
Secondary outcomes (3)
Duration of mechanical ventilation of patients with Acute respiratory distress syndrome (ARDS)
Compare clinical and developmental characteristics of ARDS diagnosed at altitudes greater than 1500 meters above sea level with those of cases diagnosed at altitudes below 1500 meters above sea level
Measured: 1 month
Length of ICU stay of patients with Acute respiratory distress syndrome (ARDS)
Measured: 1 month
Mortality of Acute respiratory distress syndrome (ARDS)
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2016 (estimated)
- Study start1 Aug 2016
- Primary completion1 Sep 2016
- Study completion1 Oct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ARDSStudies 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
- 170 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Guillermo Ortiz Ruiz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Guillermo Ortiz Ruiz, Red Latinoamericana de Medicina Intensiva de Altura
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02871063
- Sponsor's protocol ID
- RELAMI ALTURA 001
- Status last verified
- Oct 2017
- First submitted
- 1 Aug 2016
- Last updated
- 4 Oct 2017
- Results posted
- No
Publications
Bellani G, Laffey JG, Pham T, Fan E, Brochard L, Esteban A, Gattinoni L, van Haren F, Larsson A, McAuley DF, Ranieri M, Rubenfeld G, Thompson BT, Wrigge H, Slutsky AS, Pesenti A; LUNG SAFE Investigators; ESICM Trials Group. Epidemiology, Patterns of Care, and Mortality for Patients With Acute Respiratory Distress Syndrome in Intensive Care Units in 50 Countries. JAMA. 2016 Feb 23;315(8):788-800. doi: 10.1001/jama.2016.0291.
PubMed 26903337
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Altitude on the Evolution of Acute Respiratory Distress Syndrome
- ClinicalTrials.gov ID
- NCT02871063
- Acronym / sponsor ID
- RELAMI ALTURA 001
- Conditions
- ARDS, Hypoxia, Altitude, Altitude Sickness/Epidemiology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 170 participants (actual)
- Lead sponsor
- Guillermo Ortiz RuizUniversity, hospital or other
- Study start
- 1 Aug 2016 (actual)
- Primary completion
- 1 Sep 2016 (actual)
- Study completion
- 1 Oct 2016 (actual)
- First posted
- 18 Aug 2016 (estimated)
- 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.
The purpose of this piece of research is to assess the effect of altitude on the clinical evolution of ARDS. For this purpose, patients who live and receive care at sea level are compared with those who live and receive care at high altitudes. For reasons of convenience, a cut-point of 1500 meters above sea level was chosen. In addition to this, it will be sought to assess whether adjusting the cut-points for the severity categories of ARDS improves the ability to predict some adverse events, by comparison with unadjusted cut-points. The results of this research will probably be disruptive, and will provide the first information yet about the effect of altitude on ARDS; they will therefore be of great interest for the international scientific community and for the direct care of patients. A high bibliometric impact is to be expected.
Detailed description
HYPOTHESIS
Physiological adaptations generated by living at high altitude modify the clinical evolution of ARDS.
OBJECTIVE
To describe the main clinical and developmental characteristics of ARDS diagnosed at altitudes greater than 1500 meters above sea level.
To compare the main clinical and developmental characteristics of ARDS diagnosed at altitudes greater than 1500 meters above sea level with those of cases diagnosed at altitudes below 1500 meters above sea level.
METHODOLOGY
Main events:
Incidence of ARDS
Mortality of ARDS
Duration of mechanical ventilation and length of ICU stay of patients with ARDS Sequelae found 1 year and 3 years after diagnosis of ARDS
Secondary events
Recognition of ARDS by clinician
Modes of mechanical ventilation
Use of adjuvant therapies
Design: observational, prospective, cohort, multicenter, international study
Recruitment period: July 18, 2.016 - August 18, 2.016
General Procedure
The general organization chart of the study implies the participation of 3 lead researchers, at least 1 researcher/coordinator per country, and main researchers of each service.
For the selection of participating services, a general invitation will be sent to all South American ICUs located at altitudes greater than 1500 meters above sea level, as well as a representative group of ICUs located below 1500 meters above sea level.
The 2 cohorts (altitude and sea level) will be generated afterwards; the size of each cohort will be determined by convenience.
For the selection of each participating service, the exploratory form (appendix 1) will be sent beforehand, in order to gain knowledge of its characteristics and possibilities; if the center meets the criteria, it will be enrolled and the rest of the documents (research protocols, appendices 2 and 3) will be sent to it.
Once the participating services are defined, coordination videoconferences will be held before initiation of the study; an e-mail address will be set up for general coordination. All questions will be answered in less than 24 hours.
The data will be collected in an Excel spreadsheet that will be sent to the coordinator of each country, and he will distribute it to the main researcher of each participating center. The information will be afterwards submitted to the general coordinators via the reverse pathway. All information will be sent by e-mail; in order to maintain confidentiality, the spreadsheets will be encrypted. The opening codes will be known only by the researchers responsible for each service, for each country, and by the lead researchers of the study. The data will be included by the main researcher of each center, under supervision of the coordinator of each country.
Day 1 will be the day of admission to ICU with an unadjusted Pa02/Fi02 less than 300, regardless of the day the patient was admitted to hospital or to ICU.
The protocol implies the gathering of basic data (appendix 3), that will be further obtained when the patients meets the criterion of Pa02/Fi02 less than 300. Gathering of data ends 28 days after day 1 (IT MAY NOT CORRESPOND TO DAY 28 AFTER ADMISSION TO ICU); afterwards, data such as date of extubation, of discharge from ICU and from hospital, and condition upon discharge from hospital will be gathered.
Clinical and analytic data will be gathered on admission, and afterwards at the same hour of the morning, while the patient continues under invasive mechanical ventilation.
Diagnosis of ARDS is made by two procedures: (A) automatic, which will consist of individually picking each variable pertaining to the definition, and afterwards, by way of a computer algorithm, defining whether the patient complies with the Berlin definition; (B) clinical, the attending physician will be asked daily, since the moment when PaO2/Fi02<300, what the reason for hypoxemia is. Both diagnoses will be independent and double-blinded. The ratio of concordance will be calculated afterwards.
Operational definitions:
ARDS: Berlin definition.
Days free of mechanical ventilation are the number of days in which no invasive mechanical ventilation is required, from disconnection to day 28. If the patient dies, 0 days free of mechanical ventilation will be considered.
Driving pressure s the plateau pressure minus PEEP.
Incidence is the number of patients diagnosed with ARDS divided by the number of patients who required invasive mechanical ventilation over the study period.
Number of patients with ARDS per bed of the service is the number of patients diagnosed with ARDS divided by the number of beds suitable for mechanical ventilation available over the study period.
Long-term follow-up (1 and 3 years) will be carried out by the central coordination team via e-mail or, occasionally, by telephone.
Finally, a single database will be generated, with which the final report will be done.
All patients with incomplete data will be excluded from the analysis.
Statistical analysis:
In order to fulfill objective 1, a descriptive epidemiological analysis of the primary and secondary events gathered in patients diagnosed with ARDS according to the Berlin definition.
In order to fulfill objective 2, a comparison is made between the proportion of primary and secondary events between the altitude cohort and the sea-level cohort. Categorical variables are presented as number of cases and percentage, continuous variables are presented as median and percentiles 25-75. Categorical variables are compared by the chi-2 continuous variables are compared by Mann-Whitney or Kruskal-Wallis non-parametric tests.
In order to fulfill objective 3, ROC curves will be made for each event, taking into consideration the unadjusted and altitude-adjusted Berlin definition as dependent variable.
The final data report will be done following the recommendations of the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement guidelines for observational cohort studies.
The whole statistical analysis will be made with the free R program (http://www.R-project.org). All P values will be two-tail P values, considering a <0.05 level of signification.
ACCESSIBILITY OF DATA
The data will be accessible to any researcher upon written request to the Latin American Network of High-Altitude Intensive Care Medicine (RELAMI).
The request must be written in Spanish and include:
justification for using the data
commitment to using the data for exclusively scientific purposes (explicitly stating that they will not be used for economic purposes)
commitment to publishing the data in a pubmed indexed journal within a one-year period
proof of experience and background in the field of clinical research adhesion to the code of ethics
RELAMI will analyze the request and decide within a 60-day period from receipt of the request. If the response is positive, the data will be sent anonymized; if it is negative, the reasons will be explained.
ECONOMIC ASPECTS
This study does not have sponsors. No researcher will receive economic compensation or any other type of reward for participating.
ETHICAL ASPECTS
This study will be carried out in accordance with the ethical principles established by the International Conference on Harmonization, guidelines for Good Clinical Practice (GCP), which stem from the Helsinki Declaration and applicable regulation norms.
This study is considered to be of insignificant low risk, since it is an observational, non-interventional study, and the data are gathered without identification. Each participating ICU will process the pertaining institutional approvals, including a renunciation of ethical revision.
Recorded dispensation of each participant for gathering clinical data without identification will be sought as part of routine clinical care.
DATA MANAGEMENT AND DISSEMINATION OF RESULTS
The lead researchers and the Coordination Center will act as guardians of the data. Reports of progress and final reports will be presented opportunely in national and international conferences, giving priority to presentation during annual conferences in Latin America.
The results of the study will be published in indexed scientific journals, preferably of the first decile.
Only aggregated and disidentified data will be publicly presented.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High altitude ARDS | – | –ARDS diagnosed at altitudes greater than 1500 meters above sea level |
| Sea level ARDS | – | –ARDS diagnosed at altitudes below 1500 meters above sea level |
Who may qualify
- Ages
- 16 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- ARDS patients diagnosed at altitudes greater than 1500 meters above sea level and those of cases diagnosed at altitudes below 1500 meters above sea level
Key inclusion criteria (6 listed)
- Berlin definition of ARDS
- Pa02/FiO2 ≤ 300 (not corrected for altitude)
- Invasive mechanical ventilation
- Age >16 years
- Informed consent
Key exclusion criteria (3 listed)
- Pregnancy
- Under 16 years
- Not accept informed consent
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
Incidence of Acute respiratory distress syndrome (ARDS)
Time frame: 1 month
3 secondary outcomes
Duration of mechanical ventilation of patients with Acute respiratory distress syndrome (ARDS)
Time frame: 1 month
Length of ICU stay of patients with Acute respiratory distress syndrome (ARDS)
Time frame: 1 month
Mortality of Acute respiratory distress syndrome (ARDS)
Time frame: 1 month
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 4 Oct 2017.
- Background: PubMed 26903337Bellani G, Laffey JG, Pham T, Fan E, Brochard L, Esteban A, Gattinoni L, van Haren F, Larsson A, McAuley DF, Ranieri M, Rubenfeld G, Thompson BT, Wrigge H, Slutsky AS, Pesenti A; LUNG SAFE Investigators; ESICM Trials Group. Epidemiology, Patterns of Care, and Mortality for Patients With Acute Respiratory Distress Syndrome in Intensive Care Units in 50 Countries. JAMA. 2016 Feb 23;315(8):788-800. doi: 10.1001/jama.2016.0291.
- RELAMI WEB SITELink provided by the sponsor.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of ARDS and Hypoxia, Altitude, run by Guillermo Ortiz Ruiz.
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 6 inclusion and 3 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 4 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Incidence of Acute respiratory distress syndrome (ARDS) (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02871063, which also lists 1 linked publication.
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 4 Oct 2017.