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Effect of Volume and Type of Fluid on Postoperative Incidence of Respiratory Complications and Outcome (CRC-Study)

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ClinicalTrials.gov Identifier: NCT02105298
Recruitment Status : Completed
First Posted : April 7, 2014
Last Update Posted : August 21, 2015
Sponsor:
Information provided by (Responsible Party):
Matthias Eikermann, Massachusetts General Hospital

Brief 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. 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.


Condition or disease
Respiratory Failure Acute Respiratory Failure Requiring Reintubation Pulmonary Edema Pneumonia Hypoxia Acute Kidney Injury

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Study Type : Observational
Actual Enrollment : 104000 participants
Time Perspective: Prospective
Official Title: Effect of Volume and Type of Fluid on Postoperative Incidence of Respiratory Complications and Outcome (CRC-Study)
Study Start Date : September 2013
Actual Primary Completion Date : March 2014
Actual Study Completion Date : March 2014



Primary Outcome Measures :
  1. Mortality [ Time Frame: within 30 days after surgery ]
    Mortality within 30 days of surgery


Secondary Outcome Measures :
  1. Postoperative pulmonary complications [ Time Frame: 3 days after surgery ]
    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.

  2. Acute Kidney Injury [ Time Frame: within 48 hours of surgery ]
    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

  3. Post-extubation oxygen desaturation [ Time Frame: within the first 10 minutes after extubation ]
    One or more minutes with a blood oxygen saturation below 90% during the first ten minutes after extubation



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
All surgical patients aged 18 upwards receiving general anesthesia at Massachusetts General Hospital between January 2007 and November 2012
Criteria

Inclusion Criteria:

  • Ages 18 upwards
  • Tracheally intubated at the beginning of the procedure and extubated at the end of the procedure

Exclusion Criteria:

  • Cases where the subject had additional surgeries within the previous four weeks
  • Ages under 18

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02105298


Locations
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United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
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Principal Investigator: Matthias J Eikermann, M.D., Ph.D. Massachusetts General Hospital

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Responsible Party: Matthias Eikermann, M.D., Ph.D., Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT02105298     History of Changes
Other Study ID Numbers: 2013P001704
222302 ( Other Grant/Funding Number: 222302 )
First Posted: April 7, 2014    Key Record Dates
Last Update Posted: August 21, 2015
Last Verified: August 2015
Keywords provided by Matthias Eikermann, Massachusetts General Hospital:
Fluids
Intraoperative
Respiratory
Outcomes
Surgery
Anesthesia
Additional relevant MeSH terms:
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Pneumonia
Respiratory Insufficiency
Pulmonary Edema
Acute Kidney Injury
Hypoxia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Respiration Disorders
Signs and Symptoms, Respiratory
Signs and Symptoms