NCT00854386

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2009

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 25, 2009

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 3, 2009

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2009

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
Last Updated

October 15, 2009

Status Verified

October 1, 2009

Enrollment Period

2 years

First QC Date

February 25, 2009

Last Update Submit

October 14, 2009

Conditions

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

Keywords

fluid managementVATSALIARDS

Outcome Measures

Primary Outcomes (1)

  • Cardiopulmonary complications

    30 postoperative days

Secondary Outcomes (1)

  • Length of hospital stay

    30 postoperative days

Study Arms (2)

1

ACTIVE COMPARATOR

liberal fluid administration group

Drug: liberal fluid administration

2

EXPERIMENTAL

Restrictive fluid administration group

Drug: restrictive fluid administration

Interventions

liberal fluid administrationDRUG

patients in the liberal group (LG) will receive 8 ml/kg•hr of ringer lactate (RL) solution

Also known as: liberal, standard, control, high volume
1
restrictive fluid administrationDRUG

Patients in the restrictive group (RG) will receive 2 ml/kg•hr of Ringer Lactate (RL) solution throughout the intraoperative period

Also known as: restrictive, experimental, low volume
2

Eligibility Criteria

Age18 Months - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Tel Aviv Sourasky medical center

Tel Aviv, 64239, Israel

NOT YET RECRUITING

Tel Aviv Sourasky Medical Center

Tel Aviv, 64239, Israel

RECRUITING

Related Publications (9)

  • 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.

    PMID: 15983453BACKGROUND

  • 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.

    PMID: 14633519BACKGROUND

  • 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.

    PMID: 14633517BACKGROUND

  • Arieff AI. Fatal postoperative pulmonary edema: pathogenesis and literature review. Chest. 1999 May;115(5):1371-7. doi: 10.1378/chest.115.5.1371.

    PMID: 10334155BACKGROUND

  • 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.

    PMID: 17888952BACKGROUND

  • 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.

    PMID: 14578723BACKGROUND

  • 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.

    PMID: 15492573BACKGROUND

  • Weissberg D, Schachner A. Video-assisted thoracic surgery--state of the art. Ann Ital Chir. 2000 Sep-Oct;71(5):539-43.

    PMID: 11217470BACKGROUND

  • 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.

    PMID: 23558303DERIVED

MeSH Terms

Conditions

Acute Lung InjurySepsis

Interventions

Hospitals, High-VolumeHospitals, Low-Volume

Condition Hierarchy (Ancestors)

Lung InjuryLung DiseasesRespiratory Tract DiseasesInfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

HospitalsHealth FacilitiesHealth Care Facilities Workforce and Services

Study Officials

  • Idit Matot, Prof

    Tel-Aviv Sourasky Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Idit Matot, Prof

CONTACT

97236974758iditm@tasmc.health.gov.il

Yifat Klein, PhD

CONTACT

97236974093yifat.klein@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

February 25, 2009

First Posted

March 3, 2009

Study Start

May 1, 2009

Primary Completion

May 1, 2011

Study Completion

September 1, 2011

Last Updated

October 15, 2009

Record last verified: 2009-10

Locations

IL(2)