Abdomino-pelvic SurgeryNCT02908256
Comparison of Intraoperative Volume Replacement Determined by the Plethysmograph Variability Index (PVI) With That Determined by the Delta PP in the Digestive, Gynecological, Urological, and Abdominal Surgery and Their Impact on the Length of Stay
A study testing Geloplasma (PVI) and Geloplasma (delta PP) in people with Abdomino-pelvic Surgery, run by Brugmann University Hospital.
Trial summary
An optimal intraoperative fluid replacement reduces the hospital stay, the admissions in the intensive care unit and the mortality rate after a major surgery. Different criteria are used to guide the optimal vascular filling of a patient. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Abdomino-pelvic Surgery
- What is being tested?
- Geloplasma (PVI) and Geloplasma (delta PP)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Apr 2011to Mar 2016
- 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
- Abdominal-pelvic surgery (digestive, gynecologic, urologic) with laparotomy or laparoscopy
- Surgery duration superior to 1 hour
Who cannot join
- ASA score of 4
- BMI > 35
- supraventricular arrythmia (isolated extrasystoles excepted)
- cardiac insufficiency (F.E < 25 %)
- severe peripheric vascular affections
- severe respiratory affections
- terminal renal insufficiency (creatine clear and < 30 mL/min)
- gelatin allergies
About this study
Official title: Randomized Double-blind Comparison of Intraoperative Volume Replacement Determined by the Plethysmograph Variability Index (PVI) With That Determined by the Delta PP in the Digestive, Gynecological, Urological, and Abdominal Surgery and Their Impact on the Length of Stay
An optimal intraoperative fluid replacement reduces the hospital stay, the admissions in the intensive care unit and the mortality rate after a major surgery.
Different criteria are used to guide the optimal vascular filling of a patient. Among the various monitoring for the last twenty years are parameters originating from the respiratory variations of the arterial pressure curves and the pulse oximetry.
Read more
On arterial curves, the Systolic Pressure Variation (SPV) is the difference between the maximum systolic pressure (DeltaUp) and the minimal one (DeltaDown).On the oxygen saturometry curves obtained with the Masimo Radical7, the plethysmographic variability index (PVI) corresponds to the formula (PImax-PImin/PImax X 100%) where PI corresponds to the quotient expressed in % between the pulsed infrared absorption signal and the continuous absorption signal.
It has been demonstrated that the dynamic indexes were better than the static indexes to determine the response to the vascular filling. A meta-analysis showed that the dynamic changes of the variables derived from the arterial pressure curve of patients under mechanic ventilation could predict the vascular filling responsiveness with a high specificity and sensibility. The same thing applies to the variables derived from the pulsed oxymetry curves.
Furthermore, monitoring and minimizing, through the vascular filling, the variations of the pulsated arterial pressure (delta PP) induced by the mechanic ventilation during a high risk surgery allows to reduce the postoperative complications and the hospital length of stay. This has not yet been proved for the non invasive parameters (IP and PVI).
The goal of this study is thus to compare a non invasive strategy (based on PVI) to an invasive strategy (based on the deltaPP) of perioperatory filling during abdomino-pelvic interventions (digestive, gynecologic, urologic), in order to test their equivalence and measure their impact in terms of hospital stay.
This record is linked to the NCT02709252 record and share the same cohort of patients.
- Conditions
- Abdomino-pelvic Surgery
- Being tested
- Geloplasma (PVI), Geloplasma (delta PP)
- Keywords
- PVI, delta PP, vascular filling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Geloplasma (PVI)Drug
In the PVI group, a filling solution (geloplasma) will be given as a bolus of 250 ml administered in 10 minutes if the PVI>15% during more than 5 minutes. The bolus will be repeated if the PVI remains over 15%.
Geloplasma (delta PP)Drug
In the delta PP group, a filling solution (geloplasma) will be given as a bolus of 250 ml administered in 10 minutes if the delta PP> 13% during more than 5 minutes. The bolus will be repeated if the delta PP remains over 13%.
| Study group | Role | What they receive |
|---|---|---|
| PVI group | Experimental | Monitoring of the PVI during the surgical intervention Receives: Drug: Geloplasma (PVI) |
| Delta PP group | Active comparator | Monitoring of the deltaPP during the surgical intervention Receives: Drug: Geloplasma (delta PP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of hospital stay
Measured: average of 5 days
Secondary outcomes (4)
EVA score
post surgery pain scoring
Measured: up to 72 hours
number of anti-emetics administered
Measured: up to 72 hours
length of stay in recovery room
Measured: up to 24 hours
First time up
First time up/ first time sitting in a chair
Measured: up to 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2016 (estimated)
- Study startApr 2011
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Abdomino-pelvic 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brugmann University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Philippe VAN DER LINDEN, Brugmann University Hospital
- Investigators
- Philippe Van Der Linden, MD, Principal investigator, CHU Brugmann
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02908256
- Sponsor's protocol ID
- CHUB-GIFA
- Status last verified
- Jan 2018
- First submitted
- 16 Sep 2016
- Last updated
- 19 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bundgaard-Nielsen M, Holte K, Secher NH, Kehlet H. Monitoring of peri-operative fluid administration by individualized goal-directed therapy. Acta Anaesthesiol Scand. 2007 Mar;51(3):331-40. doi: 10.1111/j.1399-6576.2006.01221.x.
PubMed 17390421Marik PE, Cavallazzi R, Vasu T, Hirani A. Dynamic changes in arterial waveform derived variables and fluid responsiveness in mechanically ventilated patients: a systematic review of the literature. Crit Care Med. 2009 Sep;37(9):2642-7. doi: 10.1097/CCM.0b013e3181a590da.
PubMed 19602972Cannesson M, Desebbe O, Rosamel P, Delannoy B, Robin J, Bastien O, Lehot JJ. Pleth variability index to monitor the respiratory variations in the pulse oximeter plethysmographic waveform amplitude and predict fluid responsiveness in the operating theatre. Br J Anaesth. 2008 Aug;101(2):200-6. doi: 10.1093/bja/aen133. Epub 2008 Jun 2.
PubMed 18522935Zimmermann M, Feibicke T, Keyl C, Prasser C, Moritz S, Graf BM, Wiesenack C. Accuracy of stroke volume variation compared with pleth variability index to predict fluid responsiveness in mechanically ventilated patients undergoing major surgery. Eur J Anaesthesiol. 2010 Jun;27(6):555-61. doi: 10.1097/EJA.0b013e328335fbd1.
PubMed 20035228Michard F, Lopes MR, Auler JO Jr. Pulse pressure variation: beyond the fluid management of patients with shock. Crit Care. 2007;11(3):131. doi: 10.1186/cc5905.
PubMed 17521454Coeckelenbergh S, Delaporte A, Ghoundiwal D, Bidgoli J, Fils JF, Schmartz D, Van der Linden P. Pleth variability index versus pulse pressure variation for intraoperative goal-directed fluid therapy in patients undergoing low-to-moderate risk abdominal surgery: a randomized controlled trial. BMC Anesthesiol. 2019 Mar 9;19(1):34. doi: 10.1186/s12871-019-0707-9.
PubMed 30851740
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Double-blind Comparison of Intraoperative Volume Replacement Determined by the Plethysmograph Variability Index (PVI) With That Determined by the Delta PP in the Digestive, Gynecological, Urological, and Abdominal Surgery and Their Impact on the Length of Stay
- ClinicalTrials.gov ID
- NCT02908256
- Acronym / sponsor ID
- CHUB-GIFA
- Conditions
- Abdomino-pelvic Surgery
- Keywords
- PVI, delta PP, vascular filling
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Brugmann University HospitalUniversity, hospital or other
- Study start
- Apr 2011
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 20 Sep 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.
An optimal intraoperative fluid replacement reduces the hospital stay, the admissions in the intensive care unit and the mortality rate after a major surgery.
Different criteria are used to guide the optimal vascular filling of a patient. Among the various monitoring for the last twenty years are parameters originating from the respiratory variations of the arterial pressure curves and the pulse oximetry.
On arterial curves, the Systolic Pressure Variation (SPV) is the difference between the maximum systolic pressure (DeltaUp) and the minimal one (DeltaDown).On the oxygen saturometry curves obtained with the Masimo Radical7, the plethysmographic variability index (PVI) corresponds to the formula (PImax-PImin/PImax X 100%) where PI corresponds to the quotient expressed in % between the pulsed infrared absorption signal and the continuous absorption signal.
It has been demonstrated that the dynamic indexes were better than the static indexes to determine the response to the vascular filling. A meta-analysis showed that the dynamic changes of the variables derived from the arterial pressure curve of patients under mechanic ventilation could predict the vascular filling responsiveness with a high specificity and sensibility. The same thing applies to the variables derived from the pulsed oxymetry curves.
Furthermore, monitoring and minimizing, through the vascular filling, the variations of the pulsated arterial pressure (delta PP) induced by the mechanic ventilation during a high risk surgery allows to reduce the postoperative complications and the hospital length of stay. This has not yet been proved for the non invasive parameters (IP and PVI).
The goal of this study is thus to compare a non invasive strategy (based on PVI) to an invasive strategy (based on the deltaPP) of perioperatory filling during abdomino-pelvic interventions (digestive, gynecologic, urologic), in order to test their equivalence and measure their impact in terms of hospital stay.
This record is linked to the NCT02709252 record and share the same cohort of patients.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PVI group | Experimental | Drug: Geloplasma (PVI)Monitoring of the PVI during the surgical intervention |
| Delta PP group | Active comparator | Drug: Geloplasma (delta PP)Monitoring of the deltaPP during the surgical intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Abdominal-pelvic surgery (digestive, gynecologic, urologic) with laparotomy or laparoscopy
- Surgery duration superior to 1 hour
Key exclusion criteria (8 listed)
- ASA score of 4
- BMI > 35
- supraventricular arrythmia (isolated extrasystoles excepted)
- cardiac insufficiency (F.E < 25 %)
- severe peripheric vascular affections
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 |
|---|---|---|
| Geloplasma (PVI)In the PVI group, a filling solution (geloplasma) will be given as a bolus of 250 ml administered in 10 minutes if the PVI>15% during more than 5 minutes. The bolus will be repeated if the PVI remains over 15%. | Drug | PVI group |
| Geloplasma (delta PP)In the delta PP group, a filling solution (geloplasma) will be given as a bolus of 250 ml administered in 10 minutes if the delta PP> 13% during more than 5 minutes. The bolus will be repeated if the delta PP remains over 13%. | Drug | Delta PP group |
Primary outcome
Length of hospital stay
Time frame: average of 5 days
4 secondary outcomes
EVA score
Time frame: up to 72 hours
number of anti-emetics administered
Time frame: up to 72 hours
length of stay in recovery room
Time frame: up to 24 hours
First time up
Time frame: up to 72 hours
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 19 Jan 2018.
- Background: PubMed 17390421Bundgaard-Nielsen M, Holte K, Secher NH, Kehlet H. Monitoring of peri-operative fluid administration by individualized goal-directed therapy. Acta Anaesthesiol Scand. 2007 Mar;51(3):331-40. doi: 10.1111/j.1399-6576.2006.01221.x.
- Background: PubMed 19602972Marik PE, Cavallazzi R, Vasu T, Hirani A. Dynamic changes in arterial waveform derived variables and fluid responsiveness in mechanically ventilated patients: a systematic review of the literature. Crit Care Med. 2009 Sep;37(9):2642-7. doi: 10.1097/CCM.0b013e3181a590da.
- Background: PubMed 18522935Cannesson M, Desebbe O, Rosamel P, Delannoy B, Robin J, Bastien O, Lehot JJ. Pleth variability index to monitor the respiratory variations in the pulse oximeter plethysmographic waveform amplitude and predict fluid responsiveness in the operating theatre. Br J Anaesth. 2008 Aug;101(2):200-6. doi: 10.1093/bja/aen133. Epub 2008 Jun 2.
- Background: PubMed 20035228Zimmermann M, Feibicke T, Keyl C, Prasser C, Moritz S, Graf BM, Wiesenack C. Accuracy of stroke volume variation compared with pleth variability index to predict fluid responsiveness in mechanically ventilated patients undergoing major surgery. Eur J Anaesthesiol. 2010 Jun;27(6):555-61. doi: 10.1097/EJA.0b013e328335fbd1.
- Background: PubMed 17521454Michard F, Lopes MR, Auler JO Jr. Pulse pressure variation: beyond the fluid management of patients with shock. Crit Care. 2007;11(3):131. doi: 10.1186/cc5905.
- Derived from this study: PubMed 30851740Coeckelenbergh S, Delaporte A, Ghoundiwal D, Bidgoli J, Fils JF, Schmartz D, Van der Linden P. Pleth variability index versus pulse pressure variation for intraoperative goal-directed fluid therapy in patients undergoing low-to-moderate risk abdominal surgery: a randomized controlled trial. BMC Anesthesiol. 2019 Mar 9;19(1):34. doi: 10.1186/s12871-019-0707-9.
- Individual participant dataSharing planned: No
Related trials for Abdomino-pelvic Surgery
Active, not recruiting
A Safety and Performance Study of the Use of EmboBio for the Intra-arterial Treatment of Abdominopelvic Bleeding
Abdomino-pelvic Surgery, Bleeding
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.
Philippe Van Der Linden, MD principal investigator
CHU Brugmann
Questions about this trial
What is this clinical trial studying?
A study testing Geloplasma (PVI) and Geloplasma (delta PP) in people with Abdomino-pelvic Surgery, run by Brugmann University Hospital.
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 2 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 19 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Length of hospital stay (time frame: average of 5 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 NCT02908256, which also lists 6 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 19 Jan 2018.