search
Back to results

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

Primary Purpose

Acute Lung Injury (ALI), Acure Respiratory Distress Syndrome (ARDS), Sepsis

Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
liberal fluid administration
restrictive fluid administration
Sponsored by
Tel-Aviv Sourasky Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Lung Injury (ALI) focused on measuring fluid management, VATS, ALI, ARDS

Eligibility Criteria

18 Months - 80 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Tel Aviv Sourasky medical center
  • Tel Aviv Sourasky Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

1

2

Arm Description

liberal fluid administration group

Restrictive fluid administration group

Outcomes

Primary Outcome Measures

Cardiopulmonary complications

Secondary Outcome Measures

Length of hospital stay

Full Information

First Posted
February 25, 2009
Last Updated
October 14, 2009
Sponsor
Tel-Aviv Sourasky Medical Center
search

1. Study Identification

Unique Protocol Identification Number
NCT00854386
Brief Title
Effect of Intraoperative Fluid Restriction on Postoperative Outcomes in Video-assisted Thoracic Surgery (VATS)
Official Title
The Effect of Intraoperative Fluid Restriction on Postoperative Outcomes in Video-assisted Thoracic Surgery (VATS) for Lung Resection
Study Type
Interventional

2. Study Status

Record Verification Date
October 2009
Overall Recruitment Status
Unknown status
Study Start Date
May 2009 (undefined)
Primary Completion Date
May 2011 (Anticipated)
Study Completion Date
September 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Tel-Aviv Sourasky Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Lung Injury (ALI), Acure Respiratory Distress Syndrome (ARDS), Sepsis
Keywords
fluid management, VATS, ALI, ARDS

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
liberal fluid administration group
Arm Title
2
Arm Type
Experimental
Arm Description
Restrictive fluid administration group
Intervention Type
Drug
Intervention Name(s)
liberal fluid administration
Other Intervention Name(s)
liberal, standard, control, high volume
Intervention Description
patients in the liberal group (LG) will receive 8 ml/kg•hr of ringer lactate (RL) solution
Intervention Type
Drug
Intervention Name(s)
restrictive fluid administration
Other Intervention Name(s)
restrictive, experimental, low volume
Intervention Description
Patients in the restrictive group (RG) will receive 2 ml/kg•hr of Ringer Lactate (RL) solution throughout the intraoperative period
Primary Outcome Measure Information:
Title
Cardiopulmonary complications
Time Frame
30 postoperative days
Secondary Outcome Measure Information:
Title
Length of hospital stay
Time Frame
30 postoperative days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Months
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Idit Matot, Prof
Phone
97236974758
Email
iditm@tasmc.health.gov.il
First Name & Middle Initial & Last Name or Official Title & Degree
Yifat Klein, PhD
Phone
97236974093
Email
yifat.klein@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Idit Matot, Prof
Organizational Affiliation
Tel-Aviv Sourasky Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tel Aviv Sourasky medical center
City
Tel aviv
ZIP/Postal Code
64239
Country
Israel
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Julia Rivo, MD
Phone
97236974093
Email
juliarivo@yahoo.com
First Name & Middle Initial & Last Name & Degree
Yifat Klein, PhD
Phone
97236974093
Email
yifat.klein@gmail.com
First Name & Middle Initial & Last Name & Degree
Yifat Klein, PhD
First Name & Middle Initial & Last Name & Degree
Julia Rivo, MD
Facility Name
Tel Aviv Sourasky Medical Center
City
Tel Aviv
ZIP/Postal Code
64239
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yifat Klein, PhD
Phone
97236974093
Email
yifat.klein@gmail.com

12. IPD Sharing Statement

Citations:
PubMed Identifier
15983453
Citation
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. doi: 10.1097/00000542-200507000-00008.
Results Reference
background
PubMed Identifier
14633519
Citation
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):1558-1565. doi: 10.1213/01.ANE.0000087799.85495.8A.
Results Reference
background
PubMed Identifier
14633517
Citation
Slinger PD. Acute lung injury after pulmonary resection: more pieces of the puzzle. Anesth Analg. 2003 Dec;97(6):1555-1557. doi: 10.1213/01.ANE.0000098363.76962.A2. No abstract available.
Results Reference
background
PubMed Identifier
10334155
Citation
Arieff AI. Fatal postoperative pulmonary edema: pathogenesis and literature review. Chest. 1999 May;115(5):1371-7. doi: 10.1378/chest.115.5.1371.
Results Reference
background
PubMed Identifier
17888952
Citation
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. doi: 10.1016/j.athoracsur.2007.05.053.
Results Reference
background
PubMed Identifier
14578723
Citation
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. doi: 10.1097/01.sla.0000094387.50865.23.
Results Reference
background
PubMed Identifier
15492573
Citation
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. doi: 10.1097/01.sla.0000143269.96649.3b.
Results Reference
background
PubMed Identifier
11217470
Citation
Weissberg D, Schachner A. Video-assisted thoracic surgery--state of the art. Ann Ital Chir. 2000 Sep-Oct;71(5):539-43.
Results Reference
background
PubMed Identifier
23558303
Citation
Matot I, Dery E, Bulgov Y, Cohen B, Paz J, Nesher N. Fluid management during video-assisted thoracoscopic surgery for lung resection: a randomized, controlled trial of effects on urinary output and postoperative renal function. J Thorac Cardiovasc Surg. 2013 Aug;146(2):461-6. doi: 10.1016/j.jtcvs.2013.02.015. Epub 2013 Apr 1.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs