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
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.
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|
|Study Type :||Observational|
|Actual Enrollment :||104000 participants|
|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|
- Mortality [ Time Frame: within 30 days after surgery ]Mortality within 30 days of surgery
- 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.
- 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
- 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
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
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Principal Investigator:||Matthias J Eikermann, M.D., Ph.D.||Massachusetts General Hospital|