Effect of Intraoperative Fluid Restriction on Postoperative Outcomes in Video-assisted Thoracic Surgery (VATS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00854386
Recruitment Status : Unknown
Verified October 2009 by Tel-Aviv Sourasky Medical Center.
Recruitment status was:  Recruiting
First Posted : March 3, 2009
Last Update Posted : October 15, 2009
Information provided by:
Tel-Aviv Sourasky Medical Center

Brief Summary:
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 or disease Intervention/treatment Phase
Acute Lung Injury (ALI) Acure Respiratory Distress Syndrome (ARDS) Sepsis Drug: liberal fluid administration Drug: restrictive fluid administration Not Applicable

Detailed Description:

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.


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).

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Intraoperative Fluid Restriction on Postoperative Outcomes in Video-assisted Thoracic Surgery (VATS) for Lung Resection
Study Start Date : May 2009
Estimated Primary Completion Date : May 2011
Estimated Study Completion Date : September 2011

Arm Intervention/treatment
Active Comparator: 1
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
Other Names:
  • liberal
  • standard
  • control
  • high volume
Experimental: 2
Restrictive fluid administration group
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
Other Names:
  • restrictive
  • experimental
  • low volume

Primary Outcome Measures :
  1. Cardiopulmonary complications [ Time Frame: 30 postoperative days ]

Secondary Outcome Measures :
  1. Length of hospital stay [ Time Frame: 30 postoperative days ]

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Ages Eligible for Study:   18 Months to 80 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Age > 18 years old, with ASA I-III, undergoing elective VATS for lobectomy (of at least 2 segments), segmentectomy or pneumonectomy in the Sourasky Medical Center.

Exclusion Criteria:

  • Patients with a history of chronic renal insufficiency (creatinine > 1.5 of normal value), congestive heart failure or hepatic dysfunction.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00854386

Contact: Idit Matot, Prof 97236974758
Contact: Yifat Klein, PhD 97236974093

Tel Aviv Sourasky medical center Not yet recruiting
Tel aviv, Israel, 64239
Contact: Julia Rivo, MD    97236974093   
Contact: Yifat Klein, PhD    97236974093   
Sub-Investigator: Yifat Klein, PhD         
Sub-Investigator: Julia Rivo, MD         
Tel Aviv Sourasky Medical Center Recruiting
Tel Aviv, Israel, 64239
Contact: Yifat Klein, PhD    97236974093   
Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center
Principal Investigator: Idit Matot, Prof Tel-Aviv Sourasky Medical Center


Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Prof Idit Matot, director Anesthesiology and intensive care unit, Tel Aviv sourasky medical center Identifier: NCT00854386     History of Changes
Other Study ID Numbers: TASMC-08-IM-0502-CTIL
First Posted: March 3, 2009    Key Record Dates
Last Update Posted: October 15, 2009
Last Verified: October 2009

Keywords provided by Tel-Aviv Sourasky Medical Center:
fluid management

Additional relevant MeSH terms:
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Lung Injury
Acute Lung Injury
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Thoracic Injuries
Wounds and Injuries