Perioperative ComplicationNCT04719884
Fluid Optimisation in Laparoscopic Colorectal Procedures
A study testing Perioperative fluid optimisation in people with Perioperative Complication, run by University Medical Centre Ljubljana at 1 site in Slovenia.
Trial summary
Goal-directed fluid therapy (GDFT) with hemodynamic monitoring may not be of benefit to all elective patients undergoing major abdominal surgery, particularly those managed in Enhanced Recovery After Surgery protocols (ERAS) setting. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Perioperative Complication
- What is being tested?
- Perioperative fluid optimisation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSlovenia
- Study dates
- 1 Jun 2017to 1 Sep 2018
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients, undergoing elective laparoscopic colorectal surgery
Who cannot join
- Patients with cardiac arrhythmias
Trial locations and contacts
1 site in 1 country.
About this study
Goal-directed fluid therapy (GDFT) with hemodynamic monitoring may not be of benefit to all elective patients undergoing major abdominal surgery, particularly those managed in Enhanced Recovery After Surgery protocols (ERAS) setting.
Read the detailed description
Our study compared two groups of patients undergoing elective laparoscopic colorectal surgery: a control group (CG) in which standard haemodynamic monitoring was used, and a study group (SG) in which extended haemodynamic monitoring was applied with appropriate intraoperative interventions. Differences in intraoperative fluid management, hospital stay, and postoperative morbidity were observed.
- Conditions
- Perioperative Complication
- Being tested
- Perioperative fluid optimisation
- Keywords
- postoperative complications, intraoperative monitoring, haemodynamic monitoring, laparoscopic abdominal surgery
- Medical subject headings
- Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Perioperative fluid optimisationProcedure or surgery
In case of stroke volume variation (SVV) >10% and SI and CI >10% below the starting value, fluid challenge was performed with approximately 2 ml/kg of colloid over maximum of 5 minutes. The response was monitored.
If there was a fall in SVV and an increase in SI of >10% and the SVV still >10%, the second fluid challenge was performed.
If there was still a reduction in SVV after the second fluid challenge, but an increase in nSI <10% and decrease in systemic vascular resistance (SVR), no additional fluids were given. Vasoactive drugs were used instead.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | Standard perioperative anesthesia management |
| Study group | Active comparator | Perioperative extended haemodynamic monitoring of fluid loading, cardiac output and changes of peripheral vascular resistance by analysing the arterial curve was provided by non-invasive haemodynamic monitoring (LIDCO Rapid, Lidco Ltd., United Kingdom).In SG fluid optimisation was performed before pneumoperitoneum and after abdominal desuflation with actions to achieved CI, MAP and SI within 80% of baseline values. Receives: Procedure: Perioperative fluid optimisation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of hospitalisation
Measured: 1 month after admission
Secondary outcomes (1)
Perioperative complications
Measured: 8 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2021
- Study start1 Jun 2017
- Primary completion1 Jun 2018
- Study completion1 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perioperative ComplicationStudies of the same condition, open and under way.
- More trials run by University Medical Centre LjubljanaThe 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Centre Ljubljana
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alenka Spindler-Vesel, University Medical Centre Ljubljana
- Investigators
- Alenka Spindler Vesel, asoc Prof, Study chair, Department of anesthesiology and surgical intensive care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04719884
- Sponsor's protocol ID
- 127/5/12
- Status last verified
- Jan 2021
- First submitted
- 18 Jan 2021
- Last updated
- 22 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fluid Optimisation in Laparoscopic Colorectal Procedures
- ClinicalTrials.gov ID
- NCT04719884
- Acronym / sponsor ID
- 127/5/12
- Conditions
- Perioperative Complication
- Keywords
- postoperative complications, intraoperative monitoring, haemodynamic monitoring, laparoscopic abdominal surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University Medical Centre LjubljanaUniversity, hospital or other
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 1 Jun 2018 (actual)
- Study completion
- 1 Sep 2018 (actual)
- First posted
- 22 Jan 2021 (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.
Goal-directed fluid therapy (GDFT) with hemodynamic monitoring may not be of benefit to all elective patients undergoing major abdominal surgery, particularly those managed in Enhanced Recovery After Surgery protocols (ERAS) setting.
Detailed description
Our study compared two groups of patients undergoing elective laparoscopic colorectal surgery: a control group (CG) in which standard haemodynamic monitoring was used, and a study group (SG) in which extended haemodynamic monitoring was applied with appropriate intraoperative interventions. Differences in intraoperative fluid management, hospital stay, and postoperative morbidity were observed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –Standard perioperative anesthesia management |
| Study group | Active comparator | Procedure: Perioperative fluid optimisationPerioperative extended haemodynamic monitoring of fluid loading, cardiac output and changes of peripheral vascular resistance by analysing the arterial curve was provided by non-invasive haemodynamic monitoring (LIDCO Rapid, Lidco Ltd., United Kingdom).In SG fluid optimisation was performed before pneumoperitoneum and after abdominal desuflation with actions to achieved CI, MAP and SI within 80% of baseline values. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients, undergoing elective laparoscopic colorectal surgery
Key exclusion criteria (1 listed)
- Patients with cardiac arrhythmias
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 |
|---|---|---|
| Perioperative fluid optimisationIn case of stroke volume variation (SVV) >10% and SI and CI >10% below the starting value, fluid challenge was performed with approximately 2 ml/kg of colloid over maximum of 5 minutes. The response was monitored. If there was a fall in SVV and an increase in SI of >10% and the SVV still >10%, the second fluid challenge was performed. If there was still a reduction in SVV after the second fluid challenge, but an increase in nSI <10% and decrease in systemic vascular resistance (SVR), no additional fluids were given. Vasoactive drugs were used instead. | Procedure or surgery | Study group |
Primary outcome
Duration of hospitalisation
Time frame: 1 month after admission
1 secondary outcome
Perioperative complications
Time frame: 8 days after surgery
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 22 Jan 2021.
- Individual participant dataSharing planned: No
Related trials for Perioperative Complication
Not yet recruiting
Effect of Stress Ball Use on Perioperative Anxiety and Postoperative Pain in Parturients Undergoing Cesarean Section
Postoperative Pain
Recruiting
Studying Melatonin and Recovery in Teens
Juvenile; Scoliosis, Scoliosis Idiopathic
Not yet recruiting
Creatine and Perioperative Brain Health
Neurocognitive Disorders, Postoperative Delirium
Enrolling by invitationPhase 4
Effects of Ciprofol on Perioperative Neurocognitive Function in Elderly Patients Undergoing Daytime Surgery
PND, POCD - Postoperative Cognitive Dysfunction
Recruiting
Mechanisms and Intervention Strategies of Perioperative Glycemic Variability on Postoperative Delirium
Cardiac Surgery With Cardiopulmonary Bypass, Postoperative Delirium
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.
Alenka Spindler Vesel, asoc Prof study chair
Department of anesthesiology and surgical intensive care
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Perioperative fluid optimisation in people with Perioperative Complication, run by University Medical Centre Ljubljana at 1 site in Slovenia.
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: finished, as of the sponsor's last update on 22 Jan 2021. 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 Slovenia. 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?
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?
Duration of hospitalisation (time frame: 1 month after admission). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Jan 2021.