Acute Respiratory FailureNCT01707303
Effect Of Acute Inflammatory Mediators On Functional Limitations In Patients With Acute Respiratory Failure
A study testing Early ICU rehabilitation strategies in people with Acute Respiratory Failure, run by Wake Forest University at 1 site in United States.
Trial summary
This is a randomized, controlled, pilot study of two separate Cohorts of patients from the intensive care unit. Cohort I will enroll 50 patients and randomize to receive one physical therapy session per day or receive usual ICU care. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Respiratory Failure
- What is being tested?
- Early ICU rehabilitation strategies
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2007to Aug 2009
- Phase
- Interventional
- 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
Who may be able to join
- Mechanically ventilated via an endotracheal tube or mask
Who cannot join
- Inability to walk without assistance prior to acute ICU illness (use of a cane or walkers not exclusions)
- Cognitive impairment prior to acute ICU illness (non-verbal)
- Preadmit immunocompromised (>prednisone 20 mg/d for 2 wks)
- Acute stroke
- Body mass index (BMI) >45
- Neuromuscular disease that could impair weaning (myasthenia gravis, ALS, Guillain-Barre)
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- Hip fracture, unstable cervical spine or pathological fracture
- Mech vent >48 hours prior to transfer from an outside facility
- Current hospitalization or transferring hospital stay >72 hours
- CPR on admission, DNR on admission
- Hospitalization within 30 days prior to admission
- Cancer therapy within last 6 months
- Re-admission to ICU within current hospitalization
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest School of Medicine
Winston-Salem, North Carolina, 27157
About this study
Official title: Effect Of Acute Inflammatory Mediators On Duration Of Functional Limitations In Patients With Acute Respiratory Failure, A Randomized, Controlled Pilot Study of Early ICU Rehabilitation Strategies
This is a randomized, controlled, pilot study of two separate Cohorts of patients from the intensive care unit. Cohort I will enroll 50 patients and randomize to receive one physical therapy session per day or receive usual ICU care. Cohort II, will enroll an additional 50 patients and randomize to receive either two physical therapy sessions per day or usual care. Outcome will be length of hospital stay measured in days. Secondary outcomes will be mortality, ventilator days, ICU days, and for Cohort II, grip strength, dynamometer strength assessments and the short physical performance battery (SPPB). Study subjects will have blood for cytokine analysis through their first week of study.
- Conditions
- Acute Respiratory Failure
- Being tested
- Early ICU rehabilitation strategies, Usual Care
- Keywords
- ICU, Critical Care, Intensive Care, Critical Illness, Acute Respiratory Failure, Mechanical Ventilation, Physical Therapy, Strength, Functional Status, Short Physical Performance Battery
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early ICU rehabilitation strategiesOther
Also called Cohort I will receive one physical therapy session per day; Cohort II will receive 2 physical therapy sessions per day.
Physical therapy - standard; Physical therapy, progressive resistance training for 2nd physical therapy session in Cohort II
Usual CareOther
Also called Usual Hospital Rehabilitative Services
All typically applied hospital rehabilitative services applied in the usual fashion
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | Other | Usual hospital rehabilitative services Receives: Other: Usual Care |
| Early ICU Rehabilitation Strategy | Experimental | Early ICU physical therapy will be applied in this arm Receives: Other: Early ICU rehabilitation strategies |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospital length of stay, days
Hospital stay measured in days.
Measured: The participants will be followed for the duration of the hospitalization, an expected average of 3 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2012 (estimated)
- Study startJul 2007
- Primary completionJul 2009
- Study completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Respiratory FailureStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Peter E. Morris, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01707303
- Sponsor's protocol ID
- IRB00000240
- Status last verified
- Aug 2018
- First submitted
- 10 Oct 2012
- Last updated
- 15 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect Of Acute Inflammatory Mediators On Duration Of Functional Limitations In Patients With Acute Respiratory Failure, A Randomized, Controlled Pilot Study of Early ICU Rehabilitation Strategies
- ClinicalTrials.gov ID
- NCT01707303
- Acronym / sponsor ID
- IRB00000240
- Conditions
- Acute Respiratory Failure
- Keywords
- ICU, Critical Care, Intensive Care, Critical Illness, Acute Respiratory Failure, Mechanical Ventilation, Physical Therapy, Strength
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Wake Forest UniversityUniversity, hospital or other
- Study start
- Jul 2007
- Primary completion
- Jul 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 16 Oct 2012 (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 is a randomized, controlled, pilot study of two separate Cohorts of patients from the intensive care unit. Cohort I will enroll 50 patients and randomize to receive one physical therapy session per day or receive usual ICU care. Cohort II, will enroll an additional 50 patients and randomize to receive either two physical therapy sessions per day or usual care. Outcome will be length of hospital stay measured in days. Secondary outcomes will be mortality, ventilator days, ICU days, and for Cohort II, grip strength, dynamometer strength assessments and the short physical performance battery (SPPB). Study subjects will have blood for cytokine analysis through their first week of study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Care | Other | Other: Usual CareUsual hospital rehabilitative services |
| Early ICU Rehabilitation Strategy | Experimental | Other: Early ICU rehabilitation strategiesEarly ICU physical therapy will be applied in this arm |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Mechanically ventilated via an endotracheal tube or mask
Key exclusion criteria (13 listed)
- Inability to walk without assistance prior to acute ICU illness (use of a cane or walkers not exclusions)
- Cognitive impairment prior to acute ICU illness (non-verbal)
- Preadmit immunocompromised (>prednisone 20 mg/d for 2 wks)
- Acute stroke
- Body mass index (BMI) >45
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 |
|---|---|---|
| Early ICU rehabilitation strategiesAlso: Cohort I will receive one physical therapy session per day; Cohort II will receive 2 physical therapy sessions per day.Physical therapy - standard; Physical therapy, progressive resistance training for 2nd physical therapy session in Cohort II | Other | Early ICU Rehabilitation Strategy |
| Usual CareAlso: Usual Hospital Rehabilitative ServicesAll typically applied hospital rehabilitative services applied in the usual fashion | Other | Usual Care |
Primary outcome
Hospital length of stay, days
Time frame: The participants will be followed for the duration of the hospitalization, an expected average of 3 weeks.
Hospital stay measured in days.
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 15 Aug 2018.
- Individual participant dataSharing planned: No
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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.
Peter E. Morris, MD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early ICU rehabilitation strategies in people with Acute Respiratory Failure, run by Wake Forest University at 1 site in United States.
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 13 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 15 Aug 2018. 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 United States. 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?
Hospital length of stay, days (time frame: The participants will be followed for the duration of the hospitalization, an expected average of 3 weeks.). 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 15 Aug 2018.