Major Abdominal SurgeryPhase 2NCT02978430
Implementation of Computer-Assisted Intraoperative Goal-Directed Fluid Therapy
A Phase 2 study testing Computer-assisted GDFT in people with Major Abdominal Surgery, run by Erasme University Hospital at 1 site in Belgium.
Trial summary
The aim of this study is to compare the implementation of computer-assisted goal directed fluid therapy (GDFT) to standard of care fluid therapy in major abdominal surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Major Abdominal Surgery
- What is being tested?
- Computer-assisted GDFT
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 260 participants
- Where
- 1 siteBelgium
- Study dates
- Apr 2015to Jan 2017
- Phase
- Phase 2
- 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
- Adult patients (over the age of 18) undergoing elective major abdominal surgery that is expected to take longer than 3 hours and requiring general anesthesia.
Who cannot join
- Patients under 18 years of age
- Patients not undergoing surgery, requiring anesthesia, or cardiac output monitoring
- Patients with arrhythmia and/or atrial fibrillation
- Patients who are allergic to HES (hydroxyethyl starch)
- Patients with renal insufficiency (serum creatinine of >2 mg/ml) or hepatic dysfunction (liver enzymes >1.5)
- Patients who has coagulation disorders (values higher than 1.5x normal values)
- Patients without the capacity to give written informed consent or refusal of consent
- Pregnancy at time of enrollment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Implementation of Computer-Assisted Intraoperative Goal-Directed Fluid Therapy in Major Abdominal Surgery: A Before and After Study
The aim of this study is to compare the implementation of computer-assisted goal directed fluid therapy (GDFT) to standard of care fluid therapy in major abdominal surgery.
Read the detailed description
Fluid therapy is one of the main tools used in anesthesiology to maintain adequate hemodynamic stability. Goal-directed fluid therapy (GDFT) based on cardiac output and/or dynamic parameters of fluid responsiveness (e.g. pulse pressure variation) has been shown to decrease post-operative complications. The main inconvenience of protocol based therapy is its technical complexity which requires considerable time, attention, and vigilance. GDFT assisted by a closed-loop system, when compared to manual GDFT, is associated with a longer preload independent state and could increase clinician adherence to protocol. To this day no study has compared closed-loop assisted GDFT to standard of care.
Goal:
This study compares the results of the study entitled "Crystalloids or Colloids for Goal directed Fluid Therapy With Closed-loop Assistance in Major Surgery" (NCT02312999) to a standard of care group (started retrospectively before the first included patient of the above study) where fluid therapy is based only on static variables (e.g. arterial pressure, heart rate, central venous pressure (CVP), and urine output.) These groups consisted of the same population undergoing the same types of surgery.
Hypothesis:
A protocolized approach using computer-assisted GDFT when compared to standard of care is associated with less fluid administration and less blood transfusions.
- Conditions
- Major Abdominal Surgery
- Being tested
- Computer-assisted GDFT, Standard of care
- Keywords
- Fluid therapy, Anesthesiology, Major surgery, Goal-directed fluid therapy, Fluid responsiveness, Closed-loop system
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computer-assisted GDFTDevice
Patients receive fluid therapy via a computer-assisted goal-directed fluid therapy (GDFT) prototype closed-loop (automated) system guided by a cardiac output monitor.
Standard of careOther
Patients receive fluid management based only on static variables (e.g. arterial pressure, heart rate, CVP, and urine output). This control group (started retrospectively before the first included patient of the closed-loop goal directed fluid therapy group) consists of the same population undergoing the same surgery as the closed-loop GDFT group.
| Study group | Role | What they receive |
|---|---|---|
| Standard of care | Active comparator | This group (started retrospectively before the first included patient of the closed-loop goal-directed fluid therapy group) consists of patients undergoing major abdominal surgery where fluid management is carried out based only on static variables (e.g. arterial pressure, heart rate, CVP, and urine output). Receives: Other: Standard of care |
| Computer-assisted GDFT | Active comparator | This group consists of patients undergoing major abdominal surgery where fluid management is carried out with a closed-loop (automated) system to deliver fluid by a goal-directed fluid therapy (GDFT) standardized protocol.
Confer: "Crystalloids or Colloids for Goal-directed Fluid Therapy With Closed-loop Assistance in Major Surgery" (NCT02312999) Receives: Device: Computer-assisted GDFT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perioperative fluid administration
Fluid balance during perioperative period
Measured: 24 hours
Secondary outcomes (8)
Length of hospitalisation
Measured: Every day up to 90 days after hospitalization
Mortality rate
Measured: 30 days
Transfusion of blood products during hospitalization
In-hospital transfusion during hospitalization
Measured: Every day up to 90 days post surgery
Hypotension incidence during surgery
Incidence of hypotension (defined as total case time spent with 20% drop from baseline preoperative blood pressure)
Measured: 24 hours
Need of vasopressor
Use of vasopressors during the perioperative period
Measured: 24 hours
Renal function - urea level
Urea levels. Measured in a blood sample taken during hospitalization
Measured: Every day up to 90 days after hospitalization
Renal function - creatinine level
Creatinine levels. Measured in a blood sample taken during hospitalization
Measured: Every day up to 90 days after hospitalization
Postoperative complications
Major complications included cardiac (acute coronary syndrome/ arrhythmia), pulmonary (embolism/edema), gastrointestinal (bowel and surgical anastomotic leak/internal or external fistulas/peritoneal effusions), renal (renal failure requiring dialysis), infectious (peritonitis/ sepsis), coagulation (bleeding), wound dehiscence, stroke, reoperation, readmission, and death. Minor complications included unplanned ICU admission, pneumonia/pleural effusion, deep venous thrombosis, paralytic ileus progressive, renal insufficiency, infection (superficial wound infection/fever/urinary infection) and confusion/delirium.
Measured: Every day up to 90 days after hospitalization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2016 (estimated)
- Study startApr 2015
- Primary completionJan 2017
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Major Abdominal SurgeryStudies 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 2
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Masking
- None (open label)
- Enrolment
- 260 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erasme University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02978430
- Sponsor's protocol ID
- P2016/334
- Status last verified
- Nov 2016
- First submitted
- 22 Nov 2016
- Last updated
- 13 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Scheeren TW, Wiesenack C, Gerlach H, Marx G. Goal-directed intraoperative fluid therapy guided by stroke volume and its variation in high-risk surgical patients: a prospective randomized multicentre study. J Clin Monit Comput. 2013 Jun;27(3):225-33. doi: 10.1007/s10877-013-9461-6. Epub 2013 Apr 5.
PubMed 23558909Salzwedel C, Puig J, Carstens A, Bein B, Molnar Z, Kiss K, Hussain A, Belda J, Kirov MY, Sakka SG, Reuter DA. Perioperative goal-directed hemodynamic therapy based on radial arterial pulse pressure variation and continuous cardiac index trending reduces postoperative complications after major abdominal surgery: a multi-center, prospective, randomized study. Crit Care. 2013 Sep 8;17(5):R191. doi: 10.1186/cc12885.
PubMed 24010849Spanjersberg WR, Bergs EA, Mushkudiani N, Klimek M, Schipper IB. Protocol compliance and time management in blunt trauma resuscitation. Emerg Med J. 2009 Jan;26(1):23-7. doi: 10.1136/emj.2008.058073.
PubMed 19104091Rinehart J, Lilot M, Lee C, Joosten A, Huynh T, Canales C, Imagawa D, Demirjian A, Cannesson M. Closed-loop assisted versus manual goal-directed fluid therapy during high-risk abdominal surgery: a case-control study with propensity matching. Crit Care. 2015 Mar 19;19(1):94. doi: 10.1186/s13054-015-0827-7.
PubMed 25888403Joosten A, Coeckelenbergh S, Delaporte A, Ickx B, Closset J, Roumeguere T, Barvais L, Van Obbergh L, Cannesson M, Rinehart J, Van der Linden P. Implementation of closed-loop-assisted intra-operative goal-directed fluid therapy during major abdominal surgery: A case-control study with propensity matching. Eur J Anaesthesiol. 2018 Sep;35(9):650-658. doi: 10.1097/EJA.0000000000000827.
PubMed 29750699
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of Computer-Assisted Intraoperative Goal-Directed Fluid Therapy in Major Abdominal Surgery: A Before and After Study
- ClinicalTrials.gov ID
- NCT02978430
- Acronym / sponsor ID
- P2016/334
- Conditions
- Major Abdominal Surgery
- Keywords
- Fluid therapy, Anesthesiology, Major surgery, Goal-directed fluid therapy, Fluid responsiveness, Closed-loop system
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 260 participants (actual)
- Lead sponsor
- Erasme University HospitalUniversity, hospital or other
- Study start
- Apr 2015 (actual)
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 1 Dec 2016 (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 aim of this study is to compare the implementation of computer-assisted goal directed fluid therapy (GDFT) to standard of care fluid therapy in major abdominal surgery.
Detailed description
Fluid therapy is one of the main tools used in anesthesiology to maintain adequate hemodynamic stability. Goal-directed fluid therapy (GDFT) based on cardiac output and/or dynamic parameters of fluid responsiveness (e.g. pulse pressure variation) has been shown to decrease post-operative complications. The main inconvenience of protocol based therapy is its technical complexity which requires considerable time, attention, and vigilance. GDFT assisted by a closed-loop system, when compared to manual GDFT, is associated with a longer preload independent state and could increase clinician adherence to protocol. To this day no study has compared closed-loop assisted GDFT to standard of care.
Goal:
This study compares the results of the study entitled "Crystalloids or Colloids for Goal directed Fluid Therapy With Closed-loop Assistance in Major Surgery" (NCT02312999) to a standard of care group (started retrospectively before the first included patient of the above study) where fluid therapy is based only on static variables (e.g. arterial pressure, heart rate, central venous pressure (CVP), and urine output.) These groups consisted of the same population undergoing the same types of surgery.
Hypothesis:
A protocolized approach using computer-assisted GDFT when compared to standard of care is associated with less fluid administration and less blood transfusions.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of care | Active comparator | Other: Standard of careThis group (started retrospectively before the first included patient of the closed-loop goal-directed fluid therapy group) consists of patients undergoing major abdominal surgery where fluid management is carried out based only on static variables (e.g. arterial pressure, heart rate, CVP, and urine output). |
| Computer-assisted GDFT | Active comparator | Device: Computer-assisted GDFTThis group consists of patients undergoing major abdominal surgery where fluid management is carried out with a closed-loop (automated) system to deliver fluid by a goal-directed fluid therapy (GDFT) standardized protocol. Confer: "Crystalloids or Colloids for Goal-directed Fluid Therapy With Closed-loop Assistance in Major Surgery" (NCT02312999) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients (over the age of 18) undergoing elective major abdominal surgery that is expected to take longer than 3 hours and requiring general anesthesia.
Key exclusion criteria (8 listed)
- Patients under 18 years of age
- Patients not undergoing surgery, requiring anesthesia, or cardiac output monitoring
- Patients with arrhythmia and/or atrial fibrillation
- Patients who are allergic to HES (hydroxyethyl starch)
- Patients with renal insufficiency (serum creatinine of >2 mg/ml) or hepatic dysfunction (liver enzymes >1.5)
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 |
|---|---|---|
| Computer-assisted GDFTPatients receive fluid therapy via a computer-assisted goal-directed fluid therapy (GDFT) prototype closed-loop (automated) system guided by a cardiac output monitor. | Device | Computer-assisted GDFT |
| Standard of carePatients receive fluid management based only on static variables (e.g. arterial pressure, heart rate, CVP, and urine output). This control group (started retrospectively before the first included patient of the closed-loop goal directed fluid therapy group) consists of the same population undergoing the same surgery as the closed-loop GDFT group. | Other | Standard of care |
Primary outcome
Perioperative fluid administration
Time frame: 24 hours
Fluid balance during perioperative period
8 secondary outcomes
Length of hospitalisation
Time frame: Every day up to 90 days after hospitalization
Mortality rate
Time frame: 30 days
Transfusion of blood products during hospitalization
Time frame: Every day up to 90 days post surgery
Hypotension incidence during surgery
Time frame: 24 hours
Need of vasopressor
Time frame: 24 hours
Renal function - urea level
Time frame: Every day up to 90 days after hospitalization
Renal function - creatinine level
Time frame: Every day up to 90 days after hospitalization
Postoperative complications
Time frame: Every day up to 90 days after hospitalization
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2017.
- Background: PubMed 23558909Scheeren TW, Wiesenack C, Gerlach H, Marx G. Goal-directed intraoperative fluid therapy guided by stroke volume and its variation in high-risk surgical patients: a prospective randomized multicentre study. J Clin Monit Comput. 2013 Jun;27(3):225-33. doi: 10.1007/s10877-013-9461-6. Epub 2013 Apr 5.
- Background: PubMed 24010849Salzwedel C, Puig J, Carstens A, Bein B, Molnar Z, Kiss K, Hussain A, Belda J, Kirov MY, Sakka SG, Reuter DA. Perioperative goal-directed hemodynamic therapy based on radial arterial pulse pressure variation and continuous cardiac index trending reduces postoperative complications after major abdominal surgery: a multi-center, prospective, randomized study. Crit Care. 2013 Sep 8;17(5):R191. doi: 10.1186/cc12885.
- Background: PubMed 19104091Spanjersberg WR, Bergs EA, Mushkudiani N, Klimek M, Schipper IB. Protocol compliance and time management in blunt trauma resuscitation. Emerg Med J. 2009 Jan;26(1):23-7. doi: 10.1136/emj.2008.058073.
- Background: PubMed 25888403Rinehart J, Lilot M, Lee C, Joosten A, Huynh T, Canales C, Imagawa D, Demirjian A, Cannesson M. Closed-loop assisted versus manual goal-directed fluid therapy during high-risk abdominal surgery: a case-control study with propensity matching. Crit Care. 2015 Mar 19;19(1):94. doi: 10.1186/s13054-015-0827-7.
- Derived from this study: PubMed 29750699Joosten A, Coeckelenbergh S, Delaporte A, Ickx B, Closset J, Roumeguere T, Barvais L, Van Obbergh L, Cannesson M, Rinehart J, Van der Linden P. Implementation of closed-loop-assisted intra-operative goal-directed fluid therapy during major abdominal surgery: A case-control study with propensity matching. Eur J Anaesthesiol. 2018 Sep;35(9):650-658. doi: 10.1097/EJA.0000000000000827.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Computer-assisted GDFT in people with Major Abdominal Surgery, run by Erasme University Hospital at 1 site in Belgium.
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 8 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: finished, as of the sponsor's last update on 13 Mar 2017. 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 Belgium. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perioperative fluid administration (time frame: 24 hours). 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 NCT02978430, which also lists 5 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 13 Mar 2017.