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Sponsored by: |
Tel-Aviv Sourasky Medical Center |
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Information provided by: | Tel-Aviv Sourasky Medical Center |
ClinicalTrials.gov Identifier: | NCT00854386 |
The objective of this study is to compare the effects of two intraoperative fluid regimens - restrictive versus liberal (standard)- on postoperative outcomes (e.g. cardiopulmonary complications, morbidity, mortality and duration of hospitalization) in lung resections via Video-assisted thoracic surgery (VATS).
Condition | Intervention |
---|---|
Acute Lung Injury (ALI) Acure Respiratory Distress Syndrome (ARDS) Sepsis |
Drug: liberal fluid administration Drug: restrictive fluid administration |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Caregiver, Investigator, Outcomes Assessor), Dose Comparison, Parallel Assignment, Safety/Efficacy Study |
Official Title: | The Effect of Intraoperative Fluid Restriction on Postoperative Outcomes in Video-Assisted Thoracic Surgery (VATS) for Lung Resection |
Estimated Enrollment: | 200 |
Study Start Date: | May 2009 |
Estimated Study Completion Date: | September 2011 |
Estimated Primary Completion Date: | May 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Active Comparator
liberal fluid administration group
|
Drug: liberal fluid administration
patients in the liberal group (LG) will receive 8 ml/kg•hr of ringer lactate (RL) solution
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2: Experimental
Restrictive fluid administration group
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Drug: restrictive fluid administration
Patients in the restrictive group (RG) will receive 2 ml/kg•hr of Ringer Lactate (RL) solution throughout the intraoperative period
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Working hypothesis and aims:
The aim of this study is to investigate the effect of restrictive versus standard intraoperative fluid regimen on cardiopulmonary mordibity and mortality after VATS for lung resection. Our study hypothesis is that restrictive intraoperative fluid administration in patients undergoing VATS, will lead to better outcomes compared to a liberal fluid regimen.
Methods:
After obtaining informed consent, patients will be randomly assigned to one of two groups—liberal-protocol group (LG) or restricted-protocol group (RG).
Anesthetic and surgical management will be performed similarly and according to standards for both groups, with one exception: patients in the RG group will receive 2 ml/kg•hr whereas patients in the RL group will receive 8 ml/kg•hr of Ringer Lactate (RL) solution throughout the intraoperative period.
Hemodynamic changes during this period will be treated pharmacologically unless indicated otherwise. Blood loss, in both groups, will be replaced with RL solution in a 3:1 volume replacement, and blood and/or blood products will be transfused when required. Postoperatively, pain and fluid management will be standardized for both groups, according to departmental routines. Patient assessment will be performed by a blinded assessor. The primary endpoints of the study will combine: the incidence of post-operative complications (pulmonary, cardiovascular, others), re-intubations, and readmitions to the ICU during primary hospitalization; number of patients readmitted to the hospital within 30 days of surgery.
The secondary endpoints will include length of hospital stay, differences in hematocrit, urea, creatinine concentrations and oxygen saturation immediately postoperatively, in the first and third postoperative days and with discharge, and the number of patients receiving transfusion of blood and blood products; time to extubation, time to sit/stand/walk/eat/drink (recovery data).
Ages Eligible for Study: | 18 Months to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Idit Matot, Prof | 97236974758 | iditm@tasmc.health.gov.il |
Contact: Yifat Klein, PhD | 97236974093 | yifat.klein@gmail.com |
Israel | |
Tel Aviv Sourasky medical center | |
Tel aviv, Israel, 64239 |
Principal Investigator: | Idit Matot, Prof | Tel-Aviv Sourasky Medical Center |
Responsible Party: | Tel Aviv sourasky medical center ( Prof Idit Matot, director Anesthesiology and intensive care unit ) |
Study ID Numbers: | TASMC-08-IM-0502-CTIL |
Study First Received: | February 25, 2009 |
Last Updated: | March 2, 2009 |
ClinicalTrials.gov Identifier: | NCT00854386 History of Changes |
Health Authority: | Israel: Ministry of Health |
fluid management VATS ALI ARDS |
Sepsis Respiratory Tract Diseases Lung Diseases |
Respiration Disorders Respiratory Distress Syndrome, Adult Acute Respiratory Distress Syndrome |
Respiratory Tract Diseases Lung Diseases Respiration Disorders Respiratory Distress Syndrome, Adult |