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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2009 by Tel-Aviv Sourasky Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier:
NCT00854386
First received: February 25, 2009
Last updated: October 14, 2009
Last verified: October 2009
  Purpose

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: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Tel-Aviv Sourasky Medical Center:

Primary Outcome Measures:
  • Cardiopulmonary complications [ Time Frame: 30 postoperative days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Length of hospital stay [ Time Frame: 30 postoperative days ] [ Designated as safety issue: Yes ]

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
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

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.

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).

  Eligibility

Ages Eligible for Study:   18 Months to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00854386

Contacts
Contact: Idit Matot, Prof 97236974758 iditm@tasmc.health.gov.il
Contact: Yifat Klein, PhD 97236974093 yifat.klein@gmail.com

Locations
Israel
Tel Aviv Sourasky medical center Not yet recruiting
Tel aviv, Israel, 64239
Contact: Julia Rivo, MD    97236974093    juliarivo@yahoo.com   
Contact: Yifat Klein, PhD    97236974093    yifat.klein@gmail.com   
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    yifat.klein@gmail.com   
Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center
Investigators
Principal Investigator: Idit Matot, Prof Tel-Aviv Sourasky Medical Center
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Prof Idit Matot, director Anesthesiology and intensive care unit, Tel Aviv sourasky medical center
ClinicalTrials.gov Identifier: NCT00854386     History of Changes
Other Study ID Numbers: TASMC-08-IM-0502-CTIL
Study First Received: February 25, 2009
Last Updated: October 14, 2009
Health Authority: Israel: Ministry of Health

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

Additional relevant MeSH terms:
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Sepsis
Acute Lung Injury
Lung Injury
Wounds and Injuries
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Thoracic Injuries

ClinicalTrials.gov processed this record on July 22, 2014