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

Completed

• Conditions: Pneumonia; Hypoxia; Acute Kidney Injury; Respiratory Failure; Pulmonary Edema; Acute Respiratory Failure Requiring Reintubation

• Registration Number: NCT02105298
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-09
• Primary Completion: 2014-03
• Study Completion: 2014-03
• Study First Submitted: 2014-04-02
• Study First Submitted QC: 2014-04-02
• Study First Posted: 2014-04-07
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-19
• Last Update Posted: 2015-08-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 104000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mortality	within 30 days after surgery	Mortality within 30 days of surgery

Secondary Outcome Measures

Name	Time	Method
Post-extubation oxygen desaturation	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
Postoperative pulmonary complications	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.
Acute Kidney Injury	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

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States