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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02105298
Enrollment
104000
Registered
2014-04-07
Start date
2013-09-30
Completion date
2014-03-31
Last updated
2015-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Kidney Injury, Acute Respiratory Failure Requiring Reintubation, Hypoxia, Pneumonia, Pulmonary Edema, Respiratory Failure

Keywords

Fluids, Intraoperative, Respiratory, Outcomes, Surgery, Anesthesia

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.

Interventions

None listed

Sponsors

Massachusetts General Hospital
Lead SponsorOTHER

Study design

Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Mortalitywithin 30 days after surgeryMortality within 30 days of surgery

Secondary

MeasureTime frameDescription
Postoperative pulmonary complications3 days after surgeryThe 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 Injurywithin 48 hours of surgeryA 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 desaturationwithin the first 10 minutes after extubationOne or more minutes with a blood oxygen saturation below 90% during the first ten minutes after extubation

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026