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

NCT02105298 | Completed

• 2 other identifiers: 2013P001704222302
• Study Type: observational
• Target: 104,000
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Fluids; Intraoperative; Respiratory; Outcomes; Surgery; Anesthesia

Outcome Measures

Primary Outcomes (1)

• Mortality

  Mortality within 30 days of surgery

  within 30 days after surgery

Secondary Outcomes (3)

• Postoperative pulmonary complications

  3 days after surgery

• Acute Kidney Injury

  within 48 hours of surgery

• Post-extubation oxygen desaturation

  within the first 10 minutes after extubation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All surgical patients aged 18 upwards receiving general anesthesia at Massachusetts General Hospital between January 2007 and November 2012

You may qualify if:

• Ages 18 upwards
• Tracheally intubated at the beginning of the procedure and extubated at the end of the procedure

You may not qualify if:

• Cases where the subject had additional surgeries within the previous four weeks
• Ages under 18

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Respiratory Insufficiency; Pulmonary Edema; Pneumonia; Hypoxia; Acute Kidney Injury

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Infections; Infections; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Matthias J Eikermann, M.D., Ph.D.

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D., Ph.D.

Study Record Dates

• First Submitted: April 2, 2014
• First Posted: April 7, 2014
• Study Start: September 1, 2013
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: August 21, 2015

Record last verified: 2015-08

Locations

US (1)