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

NCT ID: NCT02105298

Last Updated: 2015-08-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

104000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-09-30

Study Completion Date

2014-03-31

Brief Summary

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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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Detailed Description

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Conditions

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

Study Design

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Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Massachusetts General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Matthias Eikermann

M.D., Ph.D.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Matthias J Eikermann, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

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Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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222302

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

2013P001704

Identifier Type: -

Identifier Source: org_study_id

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