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

Sponsor

Massachusetts General Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT02105298

Collaborator

(none)

104,000

Enrollment

Location

5.9

Duration (Months)

17489

Patients Per Site Per Month

Study Details

Study Description

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	Intervention/Treatment	Phase
Respiratory Failure Acute Respiratory Failure Requiring Reintubation Pulmonary Edema Pneumonia Hypoxia Acute Kidney Injury

Study Design

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 :

Sep 1, 2013

Actual Primary Completion Date :

Mar 1, 2014

Actual Study Completion Date :

Mar 1, 2014

Outcome Measures

Primary Outcome Measures

Mortality [within 30 days after surgery]
Mortality within 30 days of surgery

Secondary Outcome Measures

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
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