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Clinical Trials/NCT02105298
NCT02105298
Completed
Not Applicable

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

Massachusetts General Hospital1 site in 1 country104,000 target enrollmentSeptember 2013

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Respiratory Failure
Sponsor
Massachusetts General Hospital
Enrollment
104000
Locations
1
Primary Endpoint
Mortality
Status
Completed
Last Updated
10 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 2013
End Date
March 2014
Last Updated
10 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Matthias Eikermann

M.D., Ph.D.

Massachusetts General Hospital

Eligibility 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

Outcomes

Primary Outcomes

Mortality

Time Frame: within 30 days after surgery

Mortality within 30 days of surgery

Secondary Outcomes

  • Post-extubation oxygen desaturation(within the first 10 minutes after extubation)
  • Postoperative pulmonary complications(3 days after surgery)
  • Acute Kidney Injury(within 48 hours of surgery)

Study Sites (1)

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