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

Acute Kidney Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02105298
• Other study ID #: 2013P001704
• Secondary ID: 222302
• Status: Completed
• Phase: N/A
• First received: April 2, 2014
• Last updated: August 19, 2015
• Start date: September 2013
• Est. completion date: March 2014

Study information

• Verified date: August 2015
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104000
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Time Perspective: Prospective

Related Conditions & MeSH terms

• Acute Kidney Injury
• Acute Respiratory Failure Requiring Reintubation
• Hypoxia
• Pneumonia
• Pulmonary Edema
• Respiratory Distress Syndrome, Adult
• Respiratory Failure
• Respiratory Insufficiency

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality	Mortality within 30 days of surgery	within 30 days after surgery	Yes
Secondary	Postoperative pulmonary complications	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.	3 days after surgery	Yes
Secondary	Acute Kidney Injury	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	within 48 hours of surgery	Yes
Secondary	Post-extubation oxygen desaturation	One or more minutes with a blood oxygen saturation below 90% during the first ten minutes after extubation	within the first 10 minutes after extubation	Yes