Primary Peritoneal NeoplasmNCT01882920
Goal Directed Therapy (GDT) in Cytoreductive Surgery (CRS) and Hyperthermic Intra Peritoneal Chemotherapy (Hipec)
A study testing Goal Directed Intravenous Restrictive Fluid Therapy and Conventional Intravenous Fluid therapy in people with Primary Peritoneal Neoplasm and Secondary Peritoneal Neoplasm, run by Regina Elena Cancer Institute at 1 site in Italy.
Trial summary
The aim of the study is to assess whether in cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC) the use of a protocol of intravenous fluid therapy combined with goal directed fluid therapy (GDT) is associated with a significant change in morbidity, length of hospital stay and mortality… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Peritoneal Neoplasm, Secondary Peritoneal Neoplasm
- What is being tested?
- Goal Directed Intravenous Restrictive Fluid Therapy and Conventional Intravenous Fluid therapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteItaly
- Study dates
- Jun 2010to Sep 2012
- 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 selected for Cytoreductive surgery and hyperthermic intraperitoneal chemotherapy
Who cannot join
- Patients under the age of 18, patients with hemodynamically significant aortic regurgitation and heart rhythm disorders
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cytoreductive Surgery With Hyperthermic Intra-Peritoneal Chemotherapy (HIPEC) - Goal Directed Therapy vs. Standard Fluid Therapy. Prospective Randomized Study
The aim of the study is to assess whether in cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC) the use of a protocol of intravenous fluid therapy combined with goal directed fluid therapy (GDT) is associated with a significant change in morbidity, length of hospital stay and mortality compared to a standard fluid therapy. Patients undergoing CRS and hipec are randomly divided into two treatment groups. The GDT group receive fluid intravenous therapy according to a specific treatment protocol guided by monitored hemodynamic parameters assessed using the arterial pressure signal monitoring to assess stroke volume and cardiac output via an automated pulse contour analysis (Flotrac/Vigileo®); the control group receive the standard fluid therapy (crystalloid and colloid). Fluid therapy regimen is free in the control group and targeted in the GDT group. In both groups, the investigators evaluate the incidence of major abdominal and systemic complications, the total duration of hospital stay, mortality, the total amount of fluids administered, their breakdown (crystalloid/colloid) and the total number of colloid boluses administered.
- Being tested
- Goal Directed Intravenous Restrictive Fluid Therapy, Conventional Intravenous Fluid therapy
- Keywords
- Cytoreductive surgery, hyperthermic intraperitoneal chemotherapy, Goal directed fluid therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Goal Directed Intravenous Restrictive Fluid TherapyDrug
Also called Normal Saline, Ringer's lactate, Ringer's solution, Hydroxyethyl starch 130/0,4 (HES 130,04)
Basal infusion of crystalloids (normal saline,Ringer's lactate,Ringer's solution) at 4 ml/kg/h and boluses of colloids (HES 130/0.4 ) for values of cardiac index (CI) <2.5 l/min/m2, stroke volume index (SVI) < 35 SVI ml/m2 and stroke volume variation (SVV)> 15%. In the case of CI <2.5 l/min/m2 and SVI <35 ml/m2 with SVV < 15%, an infusion with dopamine was initiated.
Conventional Intravenous Fluid therapyDrug
Also called Normal saline, Ringer's lactate, Ringer's solution
Basal infusion of crystalloid (normal saline,Ringer's lactate,Ringer's solution)variable from 4 to 12 ml/kg/hour.
| Study group | Role | What they receive |
|---|---|---|
| Goal directed therapy intravenous restricitve fluid protocol | Experimental | Not described Receives: Drug: Goal Directed Intravenous Restrictive Fluid Therapy |
| Control arm | Active comparator | Not described Receives: Drug: Conventional Intravenous Fluid therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
rate of abdominal complications
Measured: 90 day postoperative complication
Secondary outcomes (1)
Overall Survival
Measured: 90 day overall survival
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2013 (estimated)
- Study startJun 2010
- Primary completionJun 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Peritoneal NeoplasmStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Regina Elena Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ester Forastiere, Regina Elena Cancer Institute
- Investigators
- Ester Forastiere, M.D., Principal investigator, Regina Elena CI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01882920
- Sponsor's protocol ID
- 89/10
- Status last verified
- Apr 2017
- First submitted
- 10 Jun 2013
- Last updated
- 26 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cytoreductive Surgery With Hyperthermic Intra-Peritoneal Chemotherapy (HIPEC) - Goal Directed Therapy vs. Standard Fluid Therapy. Prospective Randomized Study
- ClinicalTrials.gov ID
- NCT01882920
- Acronym / sponsor ID
- 89/10
- Keywords
- Cytoreductive surgery, hyperthermic intraperitoneal chemotherapy, Goal directed fluid therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Regina Elena Cancer InstituteUniversity, hospital or other
- Study start
- Jun 2010
- Primary completion
- Jun 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 21 Jun 2013 (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 the study is to assess whether in cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC) the use of a protocol of intravenous fluid therapy combined with goal directed fluid therapy (GDT) is associated with a significant change in morbidity, length of hospital stay and mortality compared to a standard fluid therapy. Patients undergoing CRS and hipec are randomly divided into two treatment groups. The GDT group receive fluid intravenous therapy according to a specific treatment protocol guided by monitored hemodynamic parameters assessed using the arterial pressure signal monitoring to assess stroke volume and cardiac output via an automated pulse contour analysis (Flotrac/Vigileo®); the control group receive the standard fluid therapy (crystalloid and colloid). Fluid therapy regimen is free in the control group and targeted in the GDT group. In both groups, the investigators evaluate the incidence of major abdominal and systemic complications, the total duration of hospital stay, mortality, the total amount of fluids administered, their breakdown (crystalloid/colloid) and the total number of colloid boluses administered.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Goal directed therapy intravenous restricitve fluid protocol | Experimental | Drug: Goal Directed Intravenous Restrictive Fluid Therapy |
| Control arm | Active comparator | Drug: Conventional Intravenous Fluid therapy |
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 selected for Cytoreductive surgery and hyperthermic intraperitoneal chemotherapy
Key exclusion criteria (1 listed)
- Patients under the age of 18, patients with hemodynamically significant aortic regurgitation and heart rhythm disorders
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 |
|---|---|---|
| Goal Directed Intravenous Restrictive Fluid TherapyAlso: Normal Saline, Ringer's lactate, Ringer's solution, Hydroxyethyl starch 130/0,4 (HES 130,04)Basal infusion of crystalloids (normal saline,Ringer's lactate,Ringer's solution) at 4 ml/kg/h and boluses of colloids (HES 130/0.4 ) for values of cardiac index (CI) <2.5 l/min/m2, stroke volume index (SVI) < 35 SVI ml/m2 and stroke volume variation (SVV)> 15%. In the case of CI <2.5 l/min/m2 and SVI <35 ml/m2 with SVV < 15%, an infusion with dopamine was initiated. | Drug | Goal directed therapy intravenous restricitve fluid protocol |
| Conventional Intravenous Fluid therapyAlso: Normal saline, Ringer's lactate, Ringer's solutionBasal infusion of crystalloid (normal saline,Ringer's lactate,Ringer's solution)variable from 4 to 12 ml/kg/hour. | Drug | Control arm |
Primary outcome
rate of abdominal complications
Time frame: 90 day postoperative complication
1 secondary outcome
Overall Survival
Time frame: 90 day overall survival
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 26 Apr 2017.
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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.
Ester Forastiere, M.D. principal investigator
Regina Elena CI
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Goal Directed Intravenous Restrictive Fluid Therapy and Conventional Intravenous Fluid therapy in people with Primary Peritoneal Neoplasm and Secondary Peritoneal Neoplasm, run by Regina Elena Cancer Institute at 1 site in Italy.
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 26 Apr 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 Italy. 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?
rate of abdominal complications (time frame: 90 day postoperative complication). 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 26 Apr 2017.