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Effect of Intraoperative Fluid Restriction on Postoperative Outcomes in Video-Assisted Thoracic Surgery (VATS)
This study is not yet open for participant recruitment.
Verified by Tel-Aviv Sourasky Medical Center, February 2009
First Received: February 25, 2009   Last Updated: March 2, 2009   History of Changes
Sponsored by: Tel-Aviv Sourasky Medical Center
Information provided by: Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier: NCT00854386
  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

MedlinePlus related topics: Sepsis Surgery
U.S. FDA Resources
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

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
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
2: Experimental
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

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
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
Tel aviv, Israel, 64239
Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center
Investigators
Principal Investigator: Idit Matot, Prof Tel-Aviv Sourasky Medical Center
  More Information

Publications:
Nisanevich V, Felsenstein I, Almogy G, Weissman C, Einav S, Matot I. Effect of intraoperative fluid management on outcome after intraabdominal surgery. Anesthesiology. 2005 Jul;103(1):25-32.
Licker M, de Perrot M, Spiliopoulos A, Robert J, Diaper J, Chevalley C, Tschopp JM. Risk factors for acute lung injury after thoracic surgery for lung cancer. Anesth Analg. 2003 Dec;97(6):1558-65.
Slinger PD. Acute lung injury after pulmonary resection: more pieces of the puzzle. Anesth Analg. 2003 Dec;97(6):1555-7. No abstract available.
Arieff AI. Fatal postoperative pulmonary edema: pathogenesis and literature review. Chest. 1999 May;115(5):1371-7. Review.
Alam N, Park BJ, Wilton A, Seshan VE, Bains MS, Downey RJ, Flores RM, Rizk N, Rusch VW, Amar D. Incidence and risk factors for lung injury after lung cancer resection. Ann Thorac Surg. 2007 Oct;84(4):1085-91; discussion 1091.
Brandstrup B, Tonnesen H, Beier-Holgersen R, Hjortso E, Ording H, Lindorff-Larsen K, Rasmussen MS, Lanng C, Wallin L, Iversen LH, Gramkow CS, Okholm M, Blemmer T, Svendsen PE, Rottensten HH, Thage B, Riis J, Jeppesen IS, Teilum D, Christensen AM, Graungaard B, Pott F; Danish Study Group on Perioperative Fluid Therapy. Effects of intravenous fluid restriction on postoperative complications: comparison of two perioperative fluid regimens: a randomized assessor-blinded multicenter trial. Ann Surg. 2003 Nov;238(5):641-8.
Holte K, Klarskov B, Christensen DS, Lund C, Nielsen KG, Bie P, Kehlet H. Liberal versus restrictive fluid administration to improve recovery after laparoscopic cholecystectomy: a randomized, double-blind study. Ann Surg. 2004 Nov;240(5):892-9.
Weissberg D, Schachner A. Video-assisted thoracic surgery--state of the art. Ann Ital Chir. 2000 Sep-Oct;71(5):539-43. Review.

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

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

Study placed in the following topic categories:
Sepsis
Respiratory Tract Diseases
Lung Diseases
Respiration Disorders
Respiratory Distress Syndrome, Adult
Acute Respiratory Distress Syndrome

Additional relevant MeSH terms:
Respiratory Tract Diseases
Lung Diseases
Respiration Disorders
Respiratory Distress Syndrome, Adult

ClinicalTrials.gov processed this record on May 06, 2009