Hematological MalignancyNCT02562105
Prognosis of Hematological Cancer Patient Underwent Mechanical Ventillation
An observational study of Hematological Malignancy and Acute Respiratory Failure, run by Mansoura University at 1 site in Egypt.
Trial summary
This observational cohort aimed to re-evaluate the outcome of hematologic cancer patients admitted to the intensive care unit of Mansoura oncology center through a cohort study as regards their need for mechanical ventilation during two years. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hematological Malignancy, Acute Respiratory Failure, Mechanical Ventilation
- What is being tested?
- Mechanical ventilation
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- Jan 2015to Sep 2015
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Hematological cancer patients admitted to ICU of oncology center, Mansoura University
Who may be able to join
- Critical ill hematological cancer patient
- Requiring mechanical ventilation
Who cannot join
- Patients with acute coronary syndrome.
- Patients with cancer remission more than 5 years.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Mansoura Cancer Therapy Center
Al Mansurah, Dakahlia Governorate, 050
About this study
Official title: In a Developing Country; What is the Fate of Hematologic Cancer Patients Requiring Mechanical Ventilation for More Than One Day? A Prospective Cohort Study
This observational cohort aimed to re-evaluate the outcome of hematologic cancer patients admitted to the intensive care unit of Mansoura oncology center through a cohort study as regards their need for mechanical ventilation during two years.
Read the detailed description
It has been believed for many years that the scene of cancer patients requiring mechanical ventilation is frustrating. The needed life support measures drain much of health resources and add a significant burden on the patient's family. Many factors have been responsible for the high mortality rates among hematologic cancer patients admitted to intensive care unit. Among of these factors, the invasive treatments that are frequently employed in today's intensive care unit. These procedures give chance for development of severe infection and multiple organ failure which are common events in immune-compromised patients (e.g. neutropenia) and in those exposed to chemotherapy. The most common form of organ failure in those patients is acute respiratory failure which is a major predictor of mortality in that population. The prognosis of such failure may vary depending on its causes and severity, co morbidity, associated acute organ failure and characters of the underlying malignancy. After the recent advances in the field of intensive care and shedding light on the benefits of the noninvasive ventilation in immune-compromised patients, the overall survival rate of cancer patients admitted to intensive care unit are improving.
- Being tested
- Mechanical ventilation
- Keywords
- Intensive care unit, Hematological malignancy, Acute respiratory failure, Prognosis, Mechanical ventilation
- Medical subject headings
- Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mechanical ventilationProcedure or surgery
requiring mechanical ventilation at admission to ICU for one day or more during the study period
| Study group | Role | What they receive |
|---|---|---|
| Mechanical ventilation | requiring mechanical ventilation at admission to ICU for one day or more during the study period Receives: Procedure: Mechanical ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival
Continuing to live
Measured: through study completion, an average of 30 days after admission to intensive care unit
Secondary outcomes (5)
Sequential Organ Failure Assessment score
Sequential Organ Failure Assessment (SOFA) Score
Measured: up to 24 hours after admission to the intensive care unit
Simplified Acute Physiology Score II
Simplified Acute Physiology Score (SAPS II)
Measured: up to 24 hours after admission to the intensive care unit
Mode of mechanical ventilation
synchronised intermittent, pressure-controlled, volume-controlled, pressure support, continuous positive airway pressure, volume guarantee, adjusted pressure release ventilation, or adaptive proportional assist ventilation
Measured: up to 24 hours after admission to the intensive care unit
lowest Pa02/FiO2
PaO2 "arterial oxygen tension"/FiO2 "inspired fraction of oxygen" ratio
Measured: up to 24 hours after admission to the intensive care unit
Reason for need of ventilatory support
Advanced malignancy, respiratory muscle weakness, respiratory failure, lung metastasis, coma, sepsis, multi-organs failure
Measured: up to 24 hours after admission to the intensive care unit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2015 (estimated)
- Study startJan 2015
- Primary completionAug 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematological MalignancyStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- 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
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Enas Aly Abd El motlb, Mansoura University
- Investigators
- Dr.Enas A Abd El motlb, MD, Principal investigator, Mansoura University, College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02562105
- Sponsor's protocol ID
- 15.05.42
- Status last verified
- Sep 2015
- First submitted
- 23 Sep 2015
- Last updated
- 29 Sep 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In a Developing Country; What is the Fate of Hematologic Cancer Patients Requiring Mechanical Ventilation for More Than One Day? A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT02562105
- Acronym / sponsor ID
- 15.05.42
- Keywords
- Intensive care unit, Hematological malignancy, Acute respiratory failure, Prognosis, Mechanical ventilation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Aug 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 29 Sep 2015 (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.
This observational cohort aimed to re-evaluate the outcome of hematologic cancer patients admitted to the intensive care unit of Mansoura oncology center through a cohort study as regards their need for mechanical ventilation during two years.
Detailed description
It has been believed for many years that the scene of cancer patients requiring mechanical ventilation is frustrating. The needed life support measures drain much of health resources and add a significant burden on the patient's family. Many factors have been responsible for the high mortality rates among hematologic cancer patients admitted to intensive care unit. Among of these factors, the invasive treatments that are frequently employed in today's intensive care unit. These procedures give chance for development of severe infection and multiple organ failure which are common events in immune-compromised patients (e.g. neutropenia) and in those exposed to chemotherapy. The most common form of organ failure in those patients is acute respiratory failure which is a major predictor of mortality in that population. The prognosis of such failure may vary depending on its causes and severity, co morbidity, associated acute organ failure and characters of the underlying malignancy. After the recent advances in the field of intensive care and shedding light on the benefits of the noninvasive ventilation in immune-compromised patients, the overall survival rate of cancer patients admitted to intensive care unit are improving.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mechanical ventilation | – | Procedure: Mechanical ventilationrequiring mechanical ventilation at admission to ICU for one day or more during the study period |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hematological cancer patients admitted to ICU of oncology center, Mansoura University
Key inclusion criteria (2 listed)
- Critical ill hematological cancer patient
- Requiring mechanical ventilation
Key exclusion criteria (2 listed)
- Patients with acute coronary syndrome.
- Patients with cancer remission more than 5 years.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mechanical ventilationrequiring mechanical ventilation at admission to ICU for one day or more during the study period | Procedure or surgery | Mechanical ventilation |
Primary outcome
Survival
Time frame: through study completion, an average of 30 days after admission to intensive care unit
Continuing to live
5 secondary outcomes
Sequential Organ Failure Assessment score
Time frame: up to 24 hours after admission to the intensive care unit
Simplified Acute Physiology Score II
Time frame: up to 24 hours after admission to the intensive care unit
Mode of mechanical ventilation
Time frame: up to 24 hours after admission to the intensive care unit
lowest Pa02/FiO2
Time frame: up to 24 hours after admission to the intensive care unit
Reason for need of ventilatory support
Time frame: up to 24 hours after admission to the intensive care unit
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 29 Sep 2015.
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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.
Dr.Enas A Abd El motlb, MD principal investigator
Mansoura University, College of Medicine
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 Hematological Malignancy and Acute Respiratory Failure, run by Mansoura University at 1 site in Egypt.
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 2 inclusion and 2 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 29 Sep 2015. 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 Egypt. 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?
Survival (time frame: through study completion, an average of 30 days after admission to intensive care unit). 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 29 Sep 2015.