Ringer's LactatePhase 4NCT03799250
Fluid Management in the Post Anesthesia Care Unit
A Phase 4 study testing Ringer lactate in people with Ringer's Lactate, run by Rabin Medical Center at 1 site in Israel.
Trial summary
Fluid therapy is a cornerstone in patient therapy perioperatively. Many studies have addressed the amount of fluid administered (restrictive vs liberal strategies). Other studies focused on the type of fluids (colloid vs crystalloids), and in the last twenty years a more common subject of research was- the correct… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ringer's Lactate
- What is being tested?
- Ringer lactate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteIsrael
- Study dates
- 30 Jun 2019to Dec 2020
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient undergoing general surgery, vascular surgery or urological surgery and who are expected to stay in the PACU for more than 8 hours.
- 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
Who cannot join
- - Pregnancy
- 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
Trial locations and contacts
1 site in 1 country.
Binyamin Zeribi contact
Israel1 site, 1 recruiting
- Recruiting
Rabin Medical Center
Petah Tikva
nadav sheffy, md, 972522246447, nadavs1@gmail.com
nadav sheffy, md
About this study
Official title: Common Clinical Indices-guided Bolus-based vs. Continuous Fluid Management A Prospective, Randomized Trial
Fluid therapy is a cornerstone in patient therapy perioperatively. Many studies have addressed the amount of fluid administered (restrictive vs liberal strategies). Other studies focused on the type of fluids (colloid vs crystalloids), and in the last twenty years a more common subject of research was- the correct evaluation of the dynamic fluid status of patients.Bolus driven fluid therapy has been investigated in many goal-directed hemodynamic therapy (GDHT) trials and has become a widely used approach in intraoperative fluid management.
While there are numerous studies on the intraoperative outcome of GDHT, research on the immediate postoperative outcome of GDHT therapy use is scarce.
Read more
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.
Read the detailed description
Methods Prior to surgery the patient will be assessed in the pre-anesthesia clinic, study protocol will be explained, questions answered and informed consent form will be signed by one of the investigating physicians. In case of an urgent case with no pre-anesthetic clinic visit, the process will take place in the entrance to the surgery room. Following surgery, patients will be assessed for eligibility and randomized to one of the study arms.
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:
- Demographic data
- Medical history including regular medications
- 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
- Anesthetic data including anesthetic method, anesthetic drugs, total fluid intake, anesthetic complications.
- Laboratory values
- Length of stay in PACU
- Length of stay in hospital
- Post-operative pulmonary complications
- Acute kidney injury
- Conditions
- Ringer's Lactate
- Being tested
- Ringer lactate, standard care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ringer lactateDrug
Comparison between fluid maintenance in PACU compared to a bolus based goal directed hemodynamic therapy in the PACU
standard careOther
standard care
| Study group | Role | What they receive |
|---|---|---|
| Goal Directed Hemodynamic Therapy | Experimental | 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. Receives: Drug: Ringer lactate |
| Control Group | Active comparator | 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. Receives: Other: standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of postoperative complications measured according to the European Perioperative Clinical Outcome definitions and Clavien-Dindo Classification in the week following the intervention
Postoperative complication rates according to the EPCO classification
Measured: 1 week post surgery
Secondary outcomes (5)
The total amount of fluid infused.
Measured: 1 week post operative
Length of stay in PACU
Measured: 8 hours after surgery
Length of stay in hospital
Measured: 1 month after surgery
Post-operative pulmonary complications
Measured: 1 week after surgery
Acute kidney injury
Measured: 1 week after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2019
- Study start30 Jun 2019
- Primary completionDec 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Ringer's LactateStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rabin Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nadav O Sheffy, MD, Principal investigator, Rabin Medical CenterLeonid O Eidelman, MD, Study chair, Rabin Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03799250
- Sponsor's protocol ID
- 824-18
- Status last verified
- Dec 2018
- First submitted
- 8 Jan 2019
- Last updated
- 25 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 23672779Pearse 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.
PubMed 16356219Della 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.
PubMed 25104915Malbouisson 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.
PubMed 28558654Gan 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.
PubMed 12357146Hand 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.
PubMed 26829494Calvo-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.
PubMed 29576114Myles 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.
PubMed 29742967Sanders 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.
PubMed 17115398Weinberg 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.
PubMed 28880931Challand 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.
PubMed 21873370Van 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.
PubMed 20613538Valentine 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.
PubMed 9510275Jammer 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.
PubMed 25058504Dindo 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.
PubMed 15273542
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Common Clinical Indices-guided Bolus-based vs. Continuous Fluid Management A Prospective, Randomized Trial
- ClinicalTrials.gov ID
- NCT03799250
- Acronym / sponsor ID
- 824-18
- Conditions
- Ringer's Lactate
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Rabin Medical CenterUniversity, hospital or other
- Study start
- 30 Jun 2019 (actual)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 10 Jan 2019 (actual)
- 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.
Fluid therapy is a cornerstone in patient therapy perioperatively. Many studies have addressed the amount of fluid administered (restrictive vs liberal strategies). Other studies focused on the type of fluids (colloid vs crystalloids), and in the last twenty years a more common subject of research was- the correct evaluation of the dynamic fluid status of patients.Bolus driven fluid therapy has been investigated in many goal-directed hemodynamic therapy (GDHT) trials and has become a widely used approach in intraoperative fluid management.
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.
Detailed description
Methods Prior to surgery the patient will be assessed in the pre-anesthesia clinic, study protocol will be explained, questions answered and informed consent form will be signed by one of the investigating physicians. In case of an urgent case with no pre-anesthetic clinic visit, the process will take place in the entrance to the surgery room. Following surgery, patients will be assessed for eligibility and randomized to one of the study arms.
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:
- Demographic data
- Medical history including regular medications
- 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
- Anesthetic data including anesthetic method, anesthetic drugs, total fluid intake, anesthetic complications.
- Laboratory values
- Length of stay in PACU
- Length of stay in hospital
- Post-operative pulmonary complications
- Acute kidney injury
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Goal Directed Hemodynamic Therapy | Experimental | Drug: Ringer lactateThe 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. |
| Control Group | Active comparator | Other: standard careThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient undergoing general surgery, vascular surgery or urological surgery and who are expected to stay in the PACU for more than 8 hours.
- 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
Key exclusion criteria (5 listed)
- - Pregnancy
- 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
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 |
|---|---|---|
| Ringer lactateComparison between fluid maintenance in PACU compared to a bolus based goal directed hemodynamic therapy in the PACU | Drug | Goal Directed Hemodynamic Therapy |
| standard carestandard care | Other | Control Group |
Primary outcome
The rate of postoperative complications measured according to the European Perioperative Clinical Outcome definitions and Clavien-Dindo Classification in the week following the intervention
Time frame: 1 week post surgery
Postoperative complication rates according to the EPCO classification
5 secondary outcomes
The total amount of fluid infused.
Time frame: 1 week post operative
Length of stay in PACU
Time frame: 8 hours after surgery
Length of stay in hospital
Time frame: 1 month after surgery
Post-operative pulmonary complications
Time frame: 1 week after surgery
Acute kidney injury
Time frame: 1 week after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2019.
- Background: PubMed 23672779Cecconi 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.
- Background: PubMed 16356219Pearse 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.
- Background: PubMed 25104915Della 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.
- Background: PubMed 28558654Malbouisson 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.
- Background: PubMed 12357146Gan 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.
- Background: PubMed 26829494Hand 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.
- Background: PubMed 29576114Calvo-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.
- Background: PubMed 29742967Myles 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.
- Background: PubMed 17115398Sanders 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.
- Background: PubMed 28880931Weinberg 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.
- Background: PubMed 21873370Challand 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.
- Background: PubMed 20613538Van 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.
- Individual participant dataSharing planned: Undecided
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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.
Binyamin Zeribi contact
Nadav O Sheffy, MD principal investigator
Rabin Medical Center
Leonid O Eidelman, MD study chair
Rabin Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ringer lactate in people with Ringer's Lactate, run by Rabin Medical Center at 1 site 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 5 inclusion and 5 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 25 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Nadav Sheffy, MD (972522246447, nadavs1@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The rate of postoperative complications measured according to the European Perioperative Clinical Outcome definitions and Clavien-Dindo Classification in the week following the intervention (time frame: 1 week post surgery). 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 NCT03799250, which also lists 15 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 25 Sep 2019.