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

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.

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Key information

Conditions

Respiratory Failure Acute Kidney Injury Acute Respiratory Failure Requiring Reintubation Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Hypoxia Infections Kidney Diseases Lung Diseases Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Pneumonia Pulmonary Edema Renal Insufficiency Respiration Disorders Respiratory Insufficiency Respiratory Tract Diseases Respiratory Tract Infections Signs and Symptoms Signs and Symptoms, Respiratory Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Mortality

Time frame: within 30 days after surgery

Mortality within 30 days of surgery

Secondary outcomes

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

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Important dates

Study start: 2013
Primary completion: 2014
Study completion: 2014
First posted: Apr 7, 2014
Registry last updated: Aug 21, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed