Acute Lung Injury (ALI)NCT00854386
Effect of Intraoperative Fluid Restriction on Postoperative Outcomes in Video-assisted Thoracic Surgery (VATS)
A study testing liberal fluid administration and restrictive fluid administration in people with Acute Lung Injury (ALI) and Acure Respiratory Distress Syndrome (ARDS), run by Tel-Aviv Sourasky Medical Center at 2 sites in Israel.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 months to 80 years
- Conditions the study is for
- Acute Lung Injury (ALI), Acure Respiratory Distress Syndrome (ARDS), Sepsis
- What is being tested?
- liberal fluid administration and restrictive fluid administration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 2 sitesIsrael
- Study dates
- May 2009to Sep 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 months to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Patients with a history of chronic renal insufficiency (creatinine > 1.5 of normal value), congestive heart failure or hepatic dysfunction.
Trial locations and contacts
2 sites in 1 country.
Israel2 sites, 2 recruiting
- Not yet recruiting
Tel Aviv Sourasky medical center
Tel Aviv, 64239
Julia Rivo, MD, 97236974093, juliarivo@yahoo.com
Yifat Klein, PhD, 97236974093, yifat.klein@gmail.com
- Recruiting
Tel Aviv Sourasky Medical Center
Tel Aviv, 64239
Yifat Klein, PhD, 97236974093, yifat.klein@gmail.com
About this study
Official title: The Effect of Intraoperative Fluid Restriction on Postoperative Outcomes in Video-assisted Thoracic Surgery (VATS) for Lung Resection
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).
Read the 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).
- Being tested
- liberal fluid administration, restrictive fluid administration
- Keywords
- fluid management, VATS, ALI, ARDS
- Medical subject headings
- Acute Lung Injury, Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
liberal fluid administrationDrug
Also called liberal, standard, control, high volume
patients in the liberal group (LG) will receive 8 ml/kg•hr of ringer lactate (RL) solution
restrictive fluid administrationDrug
Also called restrictive, experimental, low volume
Patients in the restrictive group (RG) will receive 2 ml/kg•hr of Ringer Lactate (RL) solution throughout the intraoperative period
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | liberal fluid administration group Receives: Drug: liberal fluid administration |
| 2 | Experimental | Restrictive fluid administration group Receives: Drug: restrictive fluid administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiopulmonary complications
Measured: 30 postoperative days
Secondary outcomes (1)
Length of hospital stay
Measured: 30 postoperative days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2009 (estimated)
- Study startMay 2009
- Primary completionMay 2011 (estimated)
- Study completionSep 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Acute Lung Injury (ALI)Studies of the same condition, open and under way.
- More trials run by Tel-Aviv Sourasky Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Investigators
- Idit Matot, Prof, Principal investigator, Tel-Aviv Sourasky Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00854386
- Sponsor's protocol ID
- TASMC-08-IM-0502-CTIL
- Status last verified
- Oct 2009
- First submitted
- 25 Feb 2009
- Last updated
- 15 Oct 2009
- Results posted
- No
- Data monitoring committee
- Yes
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. doi: 10.1097/00000542-200507000-00008.
PubMed 15983453Licker 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.
PubMed 14633519Slinger 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.
PubMed 14633517Arieff AI. Fatal postoperative pulmonary edema: pathogenesis and literature review. Chest. 1999 May;115(5):1371-7. doi: 10.1378/chest.115.5.1371.
PubMed 10334155Alam 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.
PubMed 17888952Brandstrup 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.
PubMed 14578723Holte 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.
PubMed 15492573Weissberg D, Schachner A. Video-assisted thoracic surgery--state of the art. Ann Ital Chir. 2000 Sep-Oct;71(5):539-43.
PubMed 11217470Matot 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.
PubMed 23558303
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Intraoperative Fluid Restriction on Postoperative Outcomes in Video-assisted Thoracic Surgery (VATS) for Lung Resection
- ClinicalTrials.gov ID
- NCT00854386
- Acronym / sponsor ID
- TASMC-08-IM-0502-CTIL
- Keywords
- fluid management, VATS, ALI, ARDS
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- May 2009
- Primary completion
- May 2011 (estimated)
- Study completion
- Sep 2011 (estimated)
- First posted
- 3 Mar 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: liberal fluid administrationliberal fluid administration group |
| 2 | Experimental | Drug: restrictive fluid administrationRestrictive fluid administration group |
Who may qualify
- Ages
- 18 months to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Patients with a history of chronic renal insufficiency (creatinine > 1.5 of normal value), congestive heart failure or hepatic dysfunction.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| liberal fluid administrationAlso: liberal, standard, control, high volumepatients in the liberal group (LG) will receive 8 ml/kg•hr of ringer lactate (RL) solution | Drug | 1 |
| restrictive fluid administrationAlso: restrictive, experimental, low volumePatients in the restrictive group (RG) will receive 2 ml/kg•hr of Ringer Lactate (RL) solution throughout the intraoperative period | Drug | 2 |
Primary outcome
Cardiopulmonary complications
Time frame: 30 postoperative days
1 secondary outcome
Length of hospital stay
Time frame: 30 postoperative days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2009.
- Background: PubMed 15983453Nisanevich 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.
- Background: PubMed 14633519Licker 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.
- Background: PubMed 14633517Slinger 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.
- Background: PubMed 10334155Arieff AI. Fatal postoperative pulmonary edema: pathogenesis and literature review. Chest. 1999 May;115(5):1371-7. doi: 10.1378/chest.115.5.1371.
- Background: PubMed 17888952Alam 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.
- Background: PubMed 14578723Brandstrup 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.
- Background: PubMed 15492573Holte 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.
- Background: PubMed 11217470Weissberg D, Schachner A. Video-assisted thoracic surgery--state of the art. Ann Ital Chir. 2000 Sep-Oct;71(5):539-43.
- Derived from this study: PubMed 23558303Matot 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.
Related trials for Acute Lung Injury (ALI)
RecruitingObservational study
Digital Early Warning System for Acute Lung Injury in Liver Surgery
Acute Lung Injury(ALI), Liver Cirrhosis
Not yet recruitingObservational study
Outer Membrane Vesicle and Ferroptosis-Related Signatures in Sepsis-Associated Acute Lung Injury Caused by Extra-Pulmonary Hypervirulent Klebsiella Pneumoniae
Sepsis, Acute Lung Injury(ALI)
RecruitingObservational study
Recovery of Physical Function After Critical Illness In Older Adults
Sepsis, Acute Lung Injury(ALI)
RecruitingObservational study
ALI & Pulmonary HA Deposition After SAH
Subarachnoid Haemorrhage (SAH)
Not yet recruiting
The Impact of Automatic Lung Recruitment Postoperative Pulmonary Complications
Acute Lung Injury
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Idit Matot, Prof principal investigator
Tel-Aviv Sourasky Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing liberal fluid administration and restrictive fluid administration in people with Acute Lung Injury (ALI) and Acure Respiratory Distress Syndrome (ARDS), run by Tel-Aviv Sourasky Medical Center at 2 sites in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Oct 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Idit Matot, Prof (97236974758, iditm@tasmc.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiopulmonary complications (time frame: 30 postoperative days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00854386, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2009.