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

Sponsor

Tel-Aviv Sourasky Medical Center (Other)

Overall Status

Unknown status

CT.gov ID

NCT00854386

Collaborator

(none)

200

Enrollment

Locations

Arms

Duration (Months)

100

Patients Per Site

3.6

Patients Per Site Per Month

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Acute Lung Injury (ALI) Acure Respiratory Distress Syndrome (ARDS) Sepsis	Drug: liberal fluid administration Drug: restrictive fluid administration	N/A

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).

Study Design

Study Type:

Interventional

Anticipated 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 1, 2009

Anticipated Primary Completion Date :

May 1, 2011

Anticipated Study Completion Date :

Sep 1, 2011

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Cardiopulmonary complications [30 postoperative days]

Secondary Outcome Measures

Length of hospital stay [30 postoperative days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Months to 80 Years

Sexes Eligible for Study:

All

Accepts 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.