Respiratory FailureNCT02105298
Effect of Volume and Type of Fluid on Postoperative Incidence of Respiratory Complications and Outcome (CRC-Study)
An observational study of Respiratory Failure and Acute Respiratory Failure Requiring Reintubation, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
Intraoperative intravenous fluid management practice varies greatly between anesthesiologists. Postoperative fluid based weight gain is associated with major morbidity. Postoperative respiratory complications are associated with increased morbidity, mortality and hospital costs. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Respiratory Failure, Acute Respiratory Failure Requiring Reintubation, Pulmonary Edema
- How many people
- 104,000 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2013to Mar 2014
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: All surgical patients aged 18 upwards receiving general anesthesia at Massachusetts General Hospital between January 2007 and November 2012
Who may be able to join
- Ages 18 upwards
- Tracheally intubated at the beginning of the procedure and extubated at the end of the procedure
Who cannot join
- Cases where the subject had additional surgeries within the previous four weeks
- Ages under 18
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Intraoperative intravenous fluid management practice varies greatly between anesthesiologists. Postoperative fluid based weight gain is associated with major morbidity. Postoperative respiratory complications are associated with increased morbidity, mortality and hospital costs. The literature shows conflicting data regarding intraoperative fluid resuscitation volume. No large-scale studies have focused on intraoperative fluid management and postoperative respiratory dysfunction.
Hypotheses:
Primary - Liberal intraoperative fluid resuscitation is associated with an increased risk of 30 day mortality Secondary - Liberal intraoperative fluid resuscitation is associated with increased likelihood of postoperative respiratory failure, pulmonary edema, reintubation, atelectasis, acute kidney injury and peri-extubation oxygen desaturation.
- Conditions
- Respiratory Failure, Acute Respiratory Failure Requiring Reintubation, Pulmonary Edema, Pneumonia, Hypoxia, Acute Kidney Injury
- Keywords
- Fluids, Intraoperative, Respiratory, Outcomes, Surgery, Anesthesia
- Medical subject headings
- Respiratory Insufficiency, Pulmonary Edema, Pneumonia, Hypoxia, Acute Kidney Injury
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Mortality within 30 days of surgery
Measured: within 30 days after surgery
Secondary outcomes (3)
Postoperative pulmonary complications
The incidence of a diagnosis of pneumonia, respiratory failure, atelectasis or pulmonary edema within 3 days after extubation in the operating room. Cases where these diagnoses were present on the day before surgery were not counted.
Measured: 3 days after surgery
Acute Kidney Injury
A Creatinine increase of >0.3mg/dl or 50% from baseline (Creatinine value closest recorded to surgery but within 30 days of surgery) to maximum value measured within 48 hours postoperatively or an ICD-9 diagnosis of AKI within 7 days of surgery but not within 30 days prior to surgery
Measured: within 48 hours of surgery
Post-extubation oxygen desaturation
One or more minutes with a blood oxygen saturation below 90% during the first ten minutes after extubation
Measured: within the first 10 minutes after extubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2014 (estimated)
- Study startSep 2013
- Primary completionMar 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory FailureStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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
- Time perspective
- Prospective
- Enrolment
- 104,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matthias Eikermann, Massachusetts General Hospital
- Investigators
- Matthias J Eikermann, M.D., Ph.D., Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02105298
- Sponsor's protocol ID
- 2013P001704
- Other IDs
- 222302
- Status last verified
- Aug 2015
- First submitted
- 2 Apr 2014
- Last updated
- 21 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Volume and Type of Fluid on Postoperative Incidence of Respiratory Complications and Outcome (CRC-Study)
- ClinicalTrials.gov ID
- NCT02105298
- Acronym / sponsor ID
- 2013P001704
- Conditions
- Respiratory Failure, Acute Respiratory Failure Requiring Reintubation, Pulmonary Edema, Pneumonia, Hypoxia, Acute Kidney Injury
- Keywords
- Fluids, Intraoperative, Respiratory, Outcomes, Surgery, Anesthesia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 104,000 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 7 Apr 2014 (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.
Intraoperative intravenous fluid management practice varies greatly between anesthesiologists. Postoperative fluid based weight gain is associated with major morbidity. Postoperative respiratory complications are associated with increased morbidity, mortality and hospital costs. The literature shows conflicting data regarding intraoperative fluid resuscitation volume. No large-scale studies have focused on intraoperative fluid management and postoperative respiratory dysfunction.
Hypotheses:
Primary - Liberal intraoperative fluid resuscitation is associated with an increased risk of 30 day mortality Secondary - Liberal intraoperative fluid resuscitation is associated with increased likelihood of postoperative respiratory failure, pulmonary edema, reintubation, atelectasis, acute kidney injury and peri-extubation oxygen desaturation.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All surgical patients aged 18 upwards receiving general anesthesia at Massachusetts General Hospital between January 2007 and November 2012
Key inclusion criteria (2 listed)
- Ages 18 upwards
- Tracheally intubated at the beginning of the procedure and extubated at the end of the procedure
Key exclusion criteria (2 listed)
- Cases where the subject had additional surgeries within the previous four weeks
- Ages under 18
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
Mortality
Time frame: within 30 days after surgery
Mortality within 30 days of surgery
3 secondary outcomes
Postoperative pulmonary complications
Time frame: 3 days after surgery
Acute Kidney Injury
Time frame: within 48 hours of surgery
Post-extubation oxygen desaturation
Time frame: within the first 10 minutes after extubation
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 21 Aug 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.
Matthias J Eikermann, M.D., Ph.D. principal investigator
Massachusetts General Hospital
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 Respiratory Failure and Acute Respiratory Failure Requiring Reintubation, run by Massachusetts General Hospital 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 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 21 Aug 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 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?
Mortality (time frame: within 30 days after surgery). 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 21 Aug 2015.