Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
200 participants
INTERVENTIONAL
2019-06-30
2020-12-31
Brief Summary
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While there are numerous studies on the intraoperative outcome of GDHT, research on the immediate postoperative outcome of GDHT therapy use is scarce.
In this study the investigators aim to evaluate the efficacy of bolus-based fluid management guided by common clinical parameters in postoperative period in post-anesthesia care unit.
In this randomized clinical trial all patients will be randomized to one of the following groups:
The control group will receive standard care which includes fluid maintenance program as dictated by the operating room anesthesiologist and as needed boluses through the PACU stay.
The GDT group will not receive any maintenance fluid. Fluid boluses will be given according to the flowchart attached.
Measurements of hemodynamic variables including heart rate and automatic non-invasive blood pressure measurements as well pulse oximetry as routine procedures will be recorded and stored by Metavision system (iMDsoft company) at regular intervals, all according to standard clinical practice.
Blood gases measurement will be performed upon admission and at discharge. Urine output will be measured and recorded every hour.
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Detailed Description
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The control group will receive standard care which includes fluid maintenance program as dictated by the operating room anesthesiologist and as needed boluses through the PACU stay.
Study Arm:
The GDT group will not receive any maintenance fluid. Fluid boluses will be given according to the flowchart attached.
Baseline MAP and HR will be measured in the pre-anesthetic clinic or if not available will be recorded according to community medical record.
Blood products will be administered according to departmental guidelines and clinician decision unrelated to participation in the study.
Patients will be extubated, either in the operating room or postoperatively, when they fulfilled standard clinical criteria (adequate protective reflexes, adequate oxygenation, and stable hemodynamics), according to clinical indication unrelated to the participation in the study.
Measurements of hemodynamic variables including heart rate and automatic non-invasive blood pressure measurements as well pulse oximetry as routine procedures will be recorded and stored by Metavision system (iMDsoft company) at regular intervals, all according to standard clinical practice.
Blood gases measurement will be performed upon admission and at discharge. Urine output will be measured and recorded every hour.
Other laboratory exams will be taken based on the physician discretion unrelated to the participation in the study.
Data Collection:
For each participating patient the following data will be collected and recorded:
1. Demographic data
2. Medical history including regular medications
3. Hemodynamic data including heart rate, automatic non-invasive blood pressure measurements, temperature as well pulse oximetry as routine procedures will be recorded and stored by Metavision system
4. Anesthetic data including anesthetic method, anesthetic drugs, total fluid intake, anesthetic complications.
5. Laboratory values
6. Length of stay in PACU
7. Length of stay in hospital
8. Post-operative pulmonary complications
9. Acute kidney injury
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Goal Directed Hemodynamic Therapy
The GDT (Goal Directed Therapy) group will not receive any maintenance fluid. Fluid boluses will be given according to the flowchart attached.
Baseline MAP and HR will be measured in the pre-anesthetic clinic or if not available will be recorded according to community medical record.
Measurements of hemodynamic variables including heart rate and automatic non-invasive blood pressure measurements as well pulse oximetry as routine procedures will be recorded and stored by Metavision system (iMDsoft company) at regular intervals, all according to standard clinical practice.
Blood gases measurement will be performed upon admission and at discharge. Urine output will be measured and recorded every hour.
Other laboratory exams will be taken based on the physician discretion unrelated to the participation in the study.
Ringer lactate
Comparison between fluid maintenance in PACU compared to a bolus based goal directed hemodynamic therapy in the PACU
Control Group
The control group will receive standard care which includes fluid maintenance program as dictated by the operating room anesthesiologist and as needed boluses through the PACU (Post Anesthesia Care Unit) stay.
standard care
standard care
Interventions
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Ringer lactate
Comparison between fluid maintenance in PACU compared to a bolus based goal directed hemodynamic therapy in the PACU
standard care
standard care
Eligibility Criteria
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Inclusion Criteria
* Above 18 years old
* Not requiring dialysis treatment
* Not requiring advanced monitoring (arterial waveform analysis or cardiac output monitoring)
* Eligible for signing an informed consent prior to surgery
Exclusion Criteria
* Inability to obtain an informed consent
* Massive transfusion in OR (more than 5 blood products)
* Colloids infusion needed
* The requirement for greater than 0.1mcg/kg/min of noradrenaline at arrival to PACU
18 Years
ALL
No
Sponsors
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Rabin Medical Center
OTHER
Responsible Party
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Principal Investigators
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Nadav O Sheffy, MD
Role: PRINCIPAL_INVESTIGATOR
Rabin Medical Center
Leonid O Eidelman, MD
Role: STUDY_CHAIR
Rabin Medical Center
Locations
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Rabin Medical Center
Petah Tikva, , Israel
Countries
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Central Contacts
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Facility Contacts
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References
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Cecconi M, Corredor C, Arulkumaran N, Abuella G, Ball J, Grounds RM, Hamilton M, Rhodes A. Clinical review: Goal-directed therapy-what is the evidence in surgical patients? The effect on different risk groups. Crit Care. 2013 Mar 5;17(2):209. doi: 10.1186/cc11823.
Pearse R, Dawson D, Fawcett J, Rhodes A, Grounds RM, Bennett ED. Early goal-directed therapy after major surgery reduces complications and duration of hospital stay. A randomised, controlled trial [ISRCTN38797445]. Crit Care. 2005;9(6):R687-93. doi: 10.1186/cc3887. Epub 2005 Nov 8.
Della Rocca G, Vetrugno L, Tripi G, Deana C, Barbariol F, Pompei L. Liberal or restricted fluid administration: are we ready for a proposal of a restricted intraoperative approach? BMC Anesthesiol. 2014 Aug 1;14:62. doi: 10.1186/1471-2253-14-62. eCollection 2014.
Malbouisson LMS, Silva JM Jr, Carmona MJC, Lopes MR, Assuncao MS, Valiatti JLDS, Simoes CM, Auler JOC Jr. A pragmatic multi-center trial of goal-directed fluid management based on pulse pressure variation monitoring during high-risk surgery. BMC Anesthesiol. 2017 May 30;17(1):70. doi: 10.1186/s12871-017-0356-9.
Gan TJ, Soppitt A, Maroof M, el-Moalem H, Robertson KM, Moretti E, Dwane P, Glass PS. Goal-directed intraoperative fluid administration reduces length of hospital stay after major surgery. Anesthesiology. 2002 Oct;97(4):820-6. doi: 10.1097/00000542-200210000-00012.
Hand WR, Stoll WD, McEvoy MD, McSwain JR, Sealy CD, Skoner JM, Hornig JD, Tennant PA, Wolf B, Day TA. Intraoperative goal-directed hemodynamic management in free tissue transfer for head and neck cancer. Head Neck. 2016 Apr;38 Suppl 1(Suppl 1):E1974-80. doi: 10.1002/hed.24362. Epub 2016 Feb 1.
Calvo-Vecino JM, Ripolles-Melchor J, Mythen MG, Casans-Frances R, Balik A, Artacho JP, Martinez-Hurtado E, Serrano Romero A, Fernandez Perez C, Asuero de Lis S; FEDORA Trial Investigators Group. Effect of goal-directed haemodynamic therapy on postoperative complications in low-moderate risk surgical patients: a multicentre randomised controlled trial (FEDORA trial). Br J Anaesth. 2018 Apr;120(4):734-744. doi: 10.1016/j.bja.2017.12.018. Epub 2018 Feb 3.
Myles PS, Bellomo R, Corcoran T, Forbes A, Peyton P, Story D, Christophi C, Leslie K, McGuinness S, Parke R, Serpell J, Chan MTV, Painter T, McCluskey S, Minto G, Wallace S; Australian and New Zealand College of Anaesthetists Clinical Trials Network and the Australian and New Zealand Intensive Care Society Clinical Trials Group. Restrictive versus Liberal Fluid Therapy for Major Abdominal Surgery. N Engl J Med. 2018 Jun 14;378(24):2263-2274. doi: 10.1056/NEJMoa1801601. Epub 2018 May 9.
Sanders GM. Randomized clinical trial assessing the effect of Doppler-optimized fluid management on outcome after elective colorectal resection (Br J Surg) 2006; 93; 1069-1076. Br J Surg. 2006 Dec;93(12):1563. doi: 10.1002/bjs.5683. No abstract available.
Weinberg L, Ianno D, Churilov L, Chao I, Scurrah N, Rachbuch C, Banting J, Muralidharan V, Story D, Bellomo R, Christophi C, Nikfarjam M. Restrictive intraoperative fluid optimisation algorithm improves outcomes in patients undergoing pancreaticoduodenectomy: A prospective multicentre randomized controlled trial. PLoS One. 2017 Sep 7;12(9):e0183313. doi: 10.1371/journal.pone.0183313. eCollection 2017.
Challand C, Struthers R, Sneyd JR, Erasmus PD, Mellor N, Hosie KB, Minto G. Randomized controlled trial of intraoperative goal-directed fluid therapy in aerobically fit and unfit patients having major colorectal surgery. Br J Anaesth. 2012 Jan;108(1):53-62. doi: 10.1093/bja/aer273. Epub 2011 Aug 26.
Van der Linden PJ, Dierick A, Wilmin S, Bellens B, De Hert SG. A randomized controlled trial comparing an intraoperative goal-directed strategy with routine clinical practice in patients undergoing peripheral arterial surgery. Eur J Anaesthesiol. 2010 Sep;27(9):788-93. doi: 10.1097/EJA.0b013e32833cb2dd.
Valentine RJ, Duke ML, Inman MH, Grayburn PA, Hagino RT, Kakish HB, Clagett GP. Effectiveness of pulmonary artery catheters in aortic surgery: a randomized trial. J Vasc Surg. 1998 Feb;27(2):203-11; discussion 211-2. doi: 10.1016/s0741-5214(98)70351-9.
Jammer I, Wickboldt N, Sander M, Smith A, Schultz MJ, Pelosi P, Leva B, Rhodes A, Hoeft A, Walder B, Chew MS, Pearse RM; European Society of Anaesthesiology (ESA) and the European Society of Intensive Care Medicine (ESICM); European Society of Anaesthesiology; European Society of Intensive Care Medicine. Standards for definitions and use of outcome measures for clinical effectiveness research in perioperative medicine: European Perioperative Clinical Outcome (EPCO) definitions: a statement from the ESA-ESICM joint taskforce on perioperative outcome measures. Eur J Anaesthesiol. 2015 Feb;32(2):88-105. doi: 10.1097/EJA.0000000000000118.
Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004 Aug;240(2):205-13. doi: 10.1097/01.sla.0000133083.54934.ae.
Other Identifiers
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824-18
Identifier Type: -
Identifier Source: org_study_id
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