Ovarian CancerHEMOPECNCT07070973
Proactive Hemodynamic Management During Cytoreductive Surgery and HIPEC
A study testing Assisted Fluid Management and Goal Directed Fluid Therapy (GDT) in people with Ovarian Cancer and Hemodynamic Instability, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial summary
Cytoreductive surgery (CRS) with hyperthermic intraperitoneal chemotherapy (HIPEC) is a complex surgical procedure carried out through laparotomic approach. After CRS-HIPEC morbidity and mortality rates go up to 20%-40% and 3% respectively, and acute kidney injury and pulmonary effusion/oedema are the most frequent… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Cancer, Hemodynamic Instability, Fluid Overload
- What is being tested?
- Assisted Fluid Management and Goal Directed Fluid Therapy (GDT)
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteItaly
- Study dates
- 1 Sep 2025to 1 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age > 18 years
- patient scheduled for CRS for ovarian cancer
Who cannot join
- patients' refusal
- cardiac arrythmia
- pregnancy.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Fondazione Policlinico A. Gemelli
Rome, 00167
Frassanito Luciano, +393475256158, luciano.frassanito@policlinicogemelli.it
Frassanito Luciano, MD
About this study
Official title: HEMOdynamic Proactive Management During Cytoreductive Surgery and Intraperitoneal hyPErthermic Chemotherapy for Advanced Ovarian Cancer
Cytoreductive surgery (CRS) with hyperthermic intraperitoneal chemotherapy (HIPEC) is a complex surgical procedure carried out through laparotomic approach. After CRS-HIPEC morbidity and mortality rates go up to 20%-40% and 3% respectively, and acute kidney injury and pulmonary effusion/oedema are the most frequent postoperative complications.
Intraoperative hypotension and risk of fluid overload are common. Efficient and accurate control of arterial pressure and cardiac output is a major concern during CRS-HIPEC.
Read more
The aim of this study is to perform a pilot study describing a hemodynamic management protocol based on artificial intelligence - derived parameters, that allows to implement the standard goal directed therapy (GDT) protocol in term of amount of IOH and stroke volume (SV) optimization.
Specifically, this study aims to test the hypotheses that a hemodynamic protocol based on HPI-AFM monitoring compared to standard GDT helps clinicians reduce IOH during surgery and improve the time "in-target" range of SV index.
The study cohort will be compared to an historical cohort of 50 patients underwent to CRS-HIPEC between 2022 and 2024, managed with an institutional goal directed therapy protocol.
Read the detailed description
Cytoreductive surgery (CRS) with hyperthermic intraperitoneal chemotherapy (HIPEC) is a complex surgical procedure carried out through laparotomic approach. Intraoperative management represents a challenge for anesthesiologist: hemodynamic instability (due to extremely destructive surgery with fluids shift and blood loss), biochemical abnormalities (worsened by cytotoxic chemotherapic agents peritoneal infusion, with profound metabolic acidosis and electrolytes disturbance), and extreme thermal fluctuations related to the different phases of surgery.
CRS-HIPEC is fraught with significant drawbacks: morbidity and mortality rates go up to 20%-40% and 3% respectively, and acute kidney injury and pulmonary effusion/oedema are the most frequent postoperative complications. More than 70% of the patients are admitted in Intensive Care Unit after the surgery.
Intraoperative hypotension (IOH) during CRS-HIPEC is common, and as it is associated with the potential for harm [9]. At the same time, extensive fluid resuscitation in peritoneal cancer patients is associated with a poor postoperative outcome, and avoiding fluid overload is recommended. Optimizing flow and pressure requires repeated measurement of both variables and use of established protocols for vasopressor and fluid administration (the so called "individualized hemodynamic management") has been shown to be associated with decreased postoperative complications compared to routine care. Efficient and accurate control of arterial pressure and cardiac output is a major concern during CRS-HIPEC, because it requires frequent manual adjustments of vasopressor infusion rates and timely fluid administration.
A peculiar aspect of CRS-HIPEC is the delicate phase of intraoperative chemotherapy. During this procedure, hyperthermia and the extensive cytolysis caused by the chemotherapeutic drug lead to multifactorial metabolic acidosis and intense vasodilation: managing fluid therapy and vasoconstrictor drugs is often extremely challenging.
The aim of this study is to perform a pilot study describing a hemodynamic management protocol based on artificial intelligence - derived parameters, that allows to implement the standard goal directed therapy (GDT) protocol in term of amount of IOH and stroke volume (SV) optimization during CRS-HIPEC.
All patients included in the study will have a radial arterial catheter inserted before or immediately after anesthesia induction and connected to Hemosphere. The clinician will follow an algorithm based on Assisted Fluid Management (AFM) for fluid infusion and on Hypotension Prediction Index (HPI) to titrate vasopressors and inotropes. AFM will be set as "medium" during cytoreductive phase and "restrictive" during HIPEC. A maximum volume of fluids per patients will be set at 10 ml/kg/hr.
Specifically, this study aims to test the hypotheses that a hemodynamic protocol based on HPI-AFM monitoring compared to standard GDT helps clinicians reduce IOH during surgery and improve the time "in-target" range of SV index (a value that estimates the time with SVI within target range, characterizing optimization of cardiac function), avoiding a detrimental fluid overload.
Two hierarchical primary endpoints were defined. The first primary endpoint will be the time-weighted average (TWA) - MAP less than 65 mmHg (expressed in mmHg) throughout surgery. The second primary endpoint will be the time spent during surgery in an optimized range of SVI (the "in target" range will be defined at the beginning of hemodynamic monitoring).
Secondary endpoints will be total norepinephrine dose and total amount of fluids.
Exploratory outcomes will be the fraction of AFM software-prompted boluses that resulted in the desired increase in SV, the incidence of post-operative complications (specifically postoperative Pulmonary Complications), ICU and hospital length of stay (LOS) and the analysis of hospital costs related to the adoption of AFM software in the clinical practice of our hospital.
The study cohort will be compared to an historical cohort of 50 patients underwent to CRS-HIPEC between 2022 and 2024, managed with an institutional goal directed therapy protocol.
- Conditions
- Ovarian Cancer, Hemodynamic Instability, Fluid Overload
- Being tested
- Assisted Fluid Management, Goal Directed Fluid Therapy (GDT)
- Medical subject headings
- Ovarian Neoplasms, Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assisted Fluid ManagementDevice
Intraoperative fluid infusion will be regulated according to the Assisted Fluid Management (AFM) software and on Hypotension Prediction Index (HPI) will be used to titrate vasopressors and inotropes.
Goal Directed Fluid Therapy (GDT)Other
Institutional goal directed therapy protocol used to optimize SVI and reduce intraoperative hypotension
| Study group | Role | What they receive |
|---|---|---|
| Proactive monitoring | Experimental | The patients will be managed following an algorithm based on Assisted Fluid Management (AFM) for fluid infusion and on Hypotension Prediction Index (HPI) to titrate vasopressors and inotropes. AFM will be set as "medium" during cytoreductive phase and "restrictive" during HIPEC. Receives: Device: Assisted Fluid Management |
| Goal Directed Fluid Therapy (GDT) | Active comparator | The patients have been managed following institutional algorithm aimed to optimize stroke volume index and reduce intraoperative hypotension Receives: Other: Goal Directed Fluid Therapy (GDT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
TWA-MAP<65mmHg
We intend to define two hierarchical primary endpoints. The first primary endpoint will be the time-weighted average (TWA) - MAP less than 65 mmHg (expressed in mmHg) throughout surgery. The second primary endpoint will be the time spent during surgery in an optimized range of SVI (the "in target" range will be defined at the beginning of hemodynamic monitoring). The optimized range of SVI is the range between the patient's baseline SVI rate and the SVI obteined after a 250 ml fluid bolus.
Measured: Perioperative
TIT-SVI
We intend to define two hierarchical primary endpoints. The first primary endpoint will be the time-weighted average (TWA) - MAP less than 65 mmHg (expressed in mmHg) throughout surgery. The second primary endpoint will be the time spent during surgery in an optimized range of SVI (the "in target" range will be defined at the beginning of hemodynamic monitoring). The optimized range of SVI is the range between the patient's baseline SVI rate and the SVI obteined after a 250 ml fluid bolus.
Measured: Perioperative
Secondary outcomes (2)
Vasopressors
Total norepinephrine dose
Measured: Perioperative
Fluids
Total amount of intraoperative fluids
Measured: Perioperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2025
- Study start1 Sep 2025
- Primary completion30 Nov 2026 (estimated)
- Study completion1 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Ovarian CancerStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Intention to treat
- Masking
- None (open label)
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, FRASSANITO LUCIANO, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Investigators
- Luciano Frassanito, Principal investigator, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07070973
- Sponsor's protocol ID
- 7488
- Acronym
- HEMOPEC
- Status last verified
- May 2026
- First submitted
- 30 Jun 2025
- Last updated
- 11 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
van Driel WJ, Koole SN, Sikorska K, Schagen van Leeuwen JH, Schreuder HWR, Hermans RHM, de Hingh IHJT, van der Velden J, Arts HJ, Massuger LFAG, Aalbers AGJ, Verwaal VJ, Kieffer JM, Van de Vijver KK, van Tinteren H, Aaronson NK, Sonke GS. Hyperthermic Intraperitoneal Chemotherapy in Ovarian Cancer. N Engl J Med. 2018 Jan 18;378(3):230-240. doi: 10.1056/NEJMoa1708618.
PubMed 29342393Ghirardi V, Trozzi R, Scanu FR, Giannarelli D, Santullo F, Costantini B, Naldini A, Panico C, Frassanito L, Scambia G, Fagotti A. Expanding the Use of HIPEC in Ovarian Cancer at Time of Interval Debulking Surgery to FIGO Stage IV and After 6 Cycles of Neoadjuvant Chemotherapy: A Prospective Analysis on Perioperative and Oncologic Outcomes. Ann Surg Oncol. 2024 May;31(5):3350-3360. doi: 10.1245/s10434-024-15042-0. Epub 2024 Feb 27.
PubMed 38411761Wang JY, Gross M, Urban RR, Jorge S. Intraperitoneal and Hyperthermic Intraperitoneal Chemotherapy for the Treatment of Ovarian Cancer. Curr Treat Options Oncol. 2024 Mar;25(3):313-329. doi: 10.1007/s11864-023-01171-3. Epub 2024 Jan 4.
PubMed 38270801Kajdi ME, Beck-Schimmer B, Held U, Kofmehl R, Lehmann K, Ganter MT. Anaesthesia in patients undergoing cytoreductive surgery with hyperthermic intraperitoneal chemotherapy: retrospective analysis of a single centre three-year experience. World J Surg Oncol. 2014 May 1;12:136. doi: 10.1186/1477-7819-12-136.
PubMed 24886171Mendonca FT, Guimaraes MM, de Matos SH, Dusi RG. Anesthetic management of Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy (CRS/HIPEC): The importance of hydro-electrolytic and acid-basic control. Int J Surg Case Rep. 2017;38:1-4. doi: 10.1016/j.ijscr.2017.07.011. Epub 2017 Jul 10.
PubMed 28719887Esteve-Perez N, Ferrer-Robles A, Gomez-Romero G, Fabian-Gonzalez D, Verd-Rodriguez M, Mora-Fernandez LC, Segura-Sampedro JJ, Tejada-Gavela S, Morales-Soriano R. Goal-directed therapy in cytoreductive surgery with hyperthermic intraperitoneal chemotherapy: a prospective observational study. Clin Transl Oncol. 2019 Apr;21(4):451-458. doi: 10.1007/s12094-018-1944-y. Epub 2018 Sep 14.
PubMed 30218305Lim MC, Chang SJ, Park B, Yoo HJ, Yoo CW, Nam BH, Park SY; HIPEC for Ovarian Cancer Collaborators. Survival After Hyperthermic Intraperitoneal Chemotherapy and Primary or Interval Cytoreductive Surgery in Ovarian Cancer: A Randomized Clinical Trial. JAMA Surg. 2022 May 1;157(5):374-383. doi: 10.1001/jamasurg.2022.0143.
PubMed 35262624Frassanito L, Giuri PP, Vassalli F, Piersanti A, Garcia MIM, Sonnino C, Zanfini BA, Catarci S, Antonelli M, Draisci G. Hypotension Prediction Index guided Goal Directed therapy and the amount of Hypotension during Major Gynaecologic Oncologic Surgery: a Randomized Controlled clinical Trial. J Clin Monit Comput. 2023 Aug;37(4):1081-1093. doi: 10.1007/s10877-023-01017-1. Epub 2023 Apr 29.
PubMed 37119322Desale MG, Tanner EJ 3rd, Sinno AK, Angarita AA, Fader AN, Stone RL, Levinson KL, Bristow RE, Roche KL. Perioperative fluid status and surgical outcomes in patients undergoing cytoreductive surgery for advanced epithelial ovarian cancer. Gynecol Oncol. 2016 Oct 28:S0090-8258(16)31501-3. doi: 10.1016/j.ygyno.2016.10.027. Online ahead of print.
PubMed 28029449Bossy M, Nyman M, Madhuri TK, Tailor A, Chatterjee J, Butler-Manuel S, Ellis P, Feldheiser A, Creagh-Brown B. The need for post-operative vasopressor infusions after major gynae-oncologic surgery within an ERAS (Enhanced Recovery After Surgery) pathway. Perioper Med (Lond). 2020 Sep 7;9:26. doi: 10.1186/s13741-020-00158-0. eCollection 2020.
PubMed 32939254Pearse RM, Harrison DA, MacDonald N, Gillies MA, Blunt M, Ackland G, Grocott MP, Ahern A, Griggs K, Scott R, Hinds C, Rowan K; OPTIMISE Study Group. Effect of a perioperative, cardiac output-guided hemodynamic therapy algorithm on outcomes following major gastrointestinal surgery: a randomized clinical trial and systematic review. JAMA. 2014 Jun 4;311(21):2181-90. doi: 10.1001/jama.2014.5305.
PubMed 24842135Joosten A, Hafiane R, Pustetto M, Van Obbergh L, Quackels T, Buggenhout A, Vincent JL, Ickx B, Rinehart J. Practical impact of a decision support for goal-directed fluid therapy on protocol adherence: a clinical implementation study in patients undergoing major abdominal surgery. J Clin Monit Comput. 2019 Feb;33(1):15-24. doi: 10.1007/s10877-018-0156-x. Epub 2018 May 19.
PubMed 29779129Maheshwari K, Malhotra G, Bao X, Lahsaei P, Hand WR, Fleming NW, Ramsingh D, Treggiari MM, Sessler DI, Miller TE; Assisted Fluid Management Study Team. Assisted Fluid Management Software Guidance for Intraoperative Fluid Administration. Anesthesiology. 2021 Aug 1;135(2):273-283. doi: 10.1097/ALN.0000000000003790.
PubMed 33901281Wijnberge M, Geerts BF, Hol L, Lemmers N, Mulder MP, Berge P, Schenk J, Terwindt LE, Hollmann MW, Vlaar AP, Veelo DP. Effect of a Machine Learning-Derived Early Warning System for Intraoperative Hypotension vs Standard Care on Depth and Duration of Intraoperative Hypotension During Elective Noncardiac Surgery: The HYPE Randomized Clinical Trial. JAMA. 2020 Mar 17;323(11):1052-1060. doi: 10.1001/jama.2020.0592.
PubMed 32065827
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HEMOdynamic Proactive Management During Cytoreductive Surgery and Intraperitoneal hyPErthermic Chemotherapy for Advanced Ovarian Cancer
- ClinicalTrials.gov ID
- NCT07070973
- Acronym / sponsor ID
- HEMOPEC / 7488
- Conditions
- Ovarian Cancer, Hemodynamic Instability, Fluid Overload
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 1 Feb 2027 (estimated)
- First posted
- 17 Jul 2025 (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.
Cytoreductive surgery (CRS) with hyperthermic intraperitoneal chemotherapy (HIPEC) is a complex surgical procedure carried out through laparotomic approach. After CRS-HIPEC morbidity and mortality rates go up to 20%-40% and 3% respectively, and acute kidney injury and pulmonary effusion/oedema are the most frequent postoperative complications.
Intraoperative hypotension and risk of fluid overload are common. Efficient and accurate control of arterial pressure and cardiac output is a major concern during CRS-HIPEC.
The aim of this study is to perform a pilot study describing a hemodynamic management protocol based on artificial intelligence - derived parameters, that allows to implement the standard goal directed therapy (GDT) protocol in term of amount of IOH and stroke volume (SV) optimization.
Specifically, this study aims to test the hypotheses that a hemodynamic protocol based on HPI-AFM monitoring compared to standard GDT helps clinicians reduce IOH during surgery and improve the time "in-target" range of SV index.
The study cohort will be compared to an historical cohort of 50 patients underwent to CRS-HIPEC between 2022 and 2024, managed with an institutional goal directed therapy protocol.
Detailed description
Cytoreductive surgery (CRS) with hyperthermic intraperitoneal chemotherapy (HIPEC) is a complex surgical procedure carried out through laparotomic approach. Intraoperative management represents a challenge for anesthesiologist: hemodynamic instability (due to extremely destructive surgery with fluids shift and blood loss), biochemical abnormalities (worsened by cytotoxic chemotherapic agents peritoneal infusion, with profound metabolic acidosis and electrolytes disturbance), and extreme thermal fluctuations related to the different phases of surgery.
CRS-HIPEC is fraught with significant drawbacks: morbidity and mortality rates go up to 20%-40% and 3% respectively, and acute kidney injury and pulmonary effusion/oedema are the most frequent postoperative complications. More than 70% of the patients are admitted in Intensive Care Unit after the surgery.
Intraoperative hypotension (IOH) during CRS-HIPEC is common, and as it is associated with the potential for harm [9]. At the same time, extensive fluid resuscitation in peritoneal cancer patients is associated with a poor postoperative outcome, and avoiding fluid overload is recommended. Optimizing flow and pressure requires repeated measurement of both variables and use of established protocols for vasopressor and fluid administration (the so called "individualized hemodynamic management") has been shown to be associated with decreased postoperative complications compared to routine care. Efficient and accurate control of arterial pressure and cardiac output is a major concern during CRS-HIPEC, because it requires frequent manual adjustments of vasopressor infusion rates and timely fluid administration.
A peculiar aspect of CRS-HIPEC is the delicate phase of intraoperative chemotherapy. During this procedure, hyperthermia and the extensive cytolysis caused by the chemotherapeutic drug lead to multifactorial metabolic acidosis and intense vasodilation: managing fluid therapy and vasoconstrictor drugs is often extremely challenging.
The aim of this study is to perform a pilot study describing a hemodynamic management protocol based on artificial intelligence - derived parameters, that allows to implement the standard goal directed therapy (GDT) protocol in term of amount of IOH and stroke volume (SV) optimization during CRS-HIPEC.
All patients included in the study will have a radial arterial catheter inserted before or immediately after anesthesia induction and connected to Hemosphere. The clinician will follow an algorithm based on Assisted Fluid Management (AFM) for fluid infusion and on Hypotension Prediction Index (HPI) to titrate vasopressors and inotropes. AFM will be set as "medium" during cytoreductive phase and "restrictive" during HIPEC. A maximum volume of fluids per patients will be set at 10 ml/kg/hr.
Specifically, this study aims to test the hypotheses that a hemodynamic protocol based on HPI-AFM monitoring compared to standard GDT helps clinicians reduce IOH during surgery and improve the time "in-target" range of SV index (a value that estimates the time with SVI within target range, characterizing optimization of cardiac function), avoiding a detrimental fluid overload.
Two hierarchical primary endpoints were defined. The first primary endpoint will be the time-weighted average (TWA) - MAP less than 65 mmHg (expressed in mmHg) throughout surgery. The second primary endpoint will be the time spent during surgery in an optimized range of SVI (the "in target" range will be defined at the beginning of hemodynamic monitoring).
Secondary endpoints will be total norepinephrine dose and total amount of fluids.
Exploratory outcomes will be the fraction of AFM software-prompted boluses that resulted in the desired increase in SV, the incidence of post-operative complications (specifically postoperative Pulmonary Complications), ICU and hospital length of stay (LOS) and the analysis of hospital costs related to the adoption of AFM software in the clinical practice of our hospital.
The study cohort will be compared to an historical cohort of 50 patients underwent to CRS-HIPEC between 2022 and 2024, managed with an institutional goal directed therapy protocol.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Intention to treat
| Arm | Type | Receives |
|---|---|---|
| Proactive monitoring | Experimental | Device: Assisted Fluid ManagementThe patients will be managed following an algorithm based on Assisted Fluid Management (AFM) for fluid infusion and on Hypotension Prediction Index (HPI) to titrate vasopressors and inotropes. AFM will be set as "medium" during cytoreductive phase and "restrictive" during HIPEC. |
| Goal Directed Fluid Therapy (GDT) | Active comparator | Other: Goal Directed Fluid Therapy (GDT)The patients have been managed following institutional algorithm aimed to optimize stroke volume index and reduce intraoperative hypotension |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- age > 18 years
- patient scheduled for CRS for ovarian cancer
Key exclusion criteria (3 listed)
- patients' refusal
- cardiac arrythmia
- pregnancy.
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 |
|---|---|---|
| Assisted Fluid ManagementIntraoperative fluid infusion will be regulated according to the Assisted Fluid Management (AFM) software and on Hypotension Prediction Index (HPI) will be used to titrate vasopressors and inotropes. | Device | Proactive monitoring |
| Goal Directed Fluid Therapy (GDT)Institutional goal directed therapy protocol used to optimize SVI and reduce intraoperative hypotension | Other | Goal Directed Fluid Therapy (GDT) |
Primary outcome
TWA-MAP<65mmHg
Time frame: Perioperative
We intend to define two hierarchical primary endpoints. The first primary endpoint will be the time-weighted average (TWA) - MAP less than 65 mmHg (expressed in mmHg) throughout surgery. The second primary endpoint will be the time spent during surgery in an optimized range of SVI (the "in target" range will be defined at the beginning of hemodynamic monitoring). The optimized range of SVI is the range between the patient's baseline SVI rate and the SVI obteined after a 250 ml fluid bolus.
TIT-SVI
Time frame: Perioperative
We intend to define two hierarchical primary endpoints. The first primary endpoint will be the time-weighted average (TWA) - MAP less than 65 mmHg (expressed in mmHg) throughout surgery. The second primary endpoint will be the time spent during surgery in an optimized range of SVI (the "in target" range will be defined at the beginning of hemodynamic monitoring). The optimized range of SVI is the range between the patient's baseline SVI rate and the SVI obteined after a 250 ml fluid bolus.
2 secondary outcomes
Vasopressors
Time frame: Perioperative
Fluids
Time frame: Perioperative
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2026.
- Results publication: PubMed 29342393van Driel WJ, Koole SN, Sikorska K, Schagen van Leeuwen JH, Schreuder HWR, Hermans RHM, de Hingh IHJT, van der Velden J, Arts HJ, Massuger LFAG, Aalbers AGJ, Verwaal VJ, Kieffer JM, Van de Vijver KK, van Tinteren H, Aaronson NK, Sonke GS. Hyperthermic Intraperitoneal Chemotherapy in Ovarian Cancer. N Engl J Med. 2018 Jan 18;378(3):230-240. doi: 10.1056/NEJMoa1708618.
- Results publication: PubMed 38411761Ghirardi V, Trozzi R, Scanu FR, Giannarelli D, Santullo F, Costantini B, Naldini A, Panico C, Frassanito L, Scambia G, Fagotti A. Expanding the Use of HIPEC in Ovarian Cancer at Time of Interval Debulking Surgery to FIGO Stage IV and After 6 Cycles of Neoadjuvant Chemotherapy: A Prospective Analysis on Perioperative and Oncologic Outcomes. Ann Surg Oncol. 2024 May;31(5):3350-3360. doi: 10.1245/s10434-024-15042-0. Epub 2024 Feb 27.
- Results publication: PubMed 38270801Wang JY, Gross M, Urban RR, Jorge S. Intraperitoneal and Hyperthermic Intraperitoneal Chemotherapy for the Treatment of Ovarian Cancer. Curr Treat Options Oncol. 2024 Mar;25(3):313-329. doi: 10.1007/s11864-023-01171-3. Epub 2024 Jan 4.
- Results publication: PubMed 24886171Kajdi ME, Beck-Schimmer B, Held U, Kofmehl R, Lehmann K, Ganter MT. Anaesthesia in patients undergoing cytoreductive surgery with hyperthermic intraperitoneal chemotherapy: retrospective analysis of a single centre three-year experience. World J Surg Oncol. 2014 May 1;12:136. doi: 10.1186/1477-7819-12-136.
- Results publication: PubMed 28719887Mendonca FT, Guimaraes MM, de Matos SH, Dusi RG. Anesthetic management of Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy (CRS/HIPEC): The importance of hydro-electrolytic and acid-basic control. Int J Surg Case Rep. 2017;38:1-4. doi: 10.1016/j.ijscr.2017.07.011. Epub 2017 Jul 10.
- Results publication: PubMed 30218305Esteve-Perez N, Ferrer-Robles A, Gomez-Romero G, Fabian-Gonzalez D, Verd-Rodriguez M, Mora-Fernandez LC, Segura-Sampedro JJ, Tejada-Gavela S, Morales-Soriano R. Goal-directed therapy in cytoreductive surgery with hyperthermic intraperitoneal chemotherapy: a prospective observational study. Clin Transl Oncol. 2019 Apr;21(4):451-458. doi: 10.1007/s12094-018-1944-y. Epub 2018 Sep 14.
- Results publication: PubMed 35262624Lim MC, Chang SJ, Park B, Yoo HJ, Yoo CW, Nam BH, Park SY; HIPEC for Ovarian Cancer Collaborators. Survival After Hyperthermic Intraperitoneal Chemotherapy and Primary or Interval Cytoreductive Surgery in Ovarian Cancer: A Randomized Clinical Trial. JAMA Surg. 2022 May 1;157(5):374-383. doi: 10.1001/jamasurg.2022.0143.
- Results publication: PubMed 37119322Frassanito L, Giuri PP, Vassalli F, Piersanti A, Garcia MIM, Sonnino C, Zanfini BA, Catarci S, Antonelli M, Draisci G. Hypotension Prediction Index guided Goal Directed therapy and the amount of Hypotension during Major Gynaecologic Oncologic Surgery: a Randomized Controlled clinical Trial. J Clin Monit Comput. 2023 Aug;37(4):1081-1093. doi: 10.1007/s10877-023-01017-1. Epub 2023 Apr 29.
- Results publication: PubMed 28029449Desale MG, Tanner EJ 3rd, Sinno AK, Angarita AA, Fader AN, Stone RL, Levinson KL, Bristow RE, Roche KL. Perioperative fluid status and surgical outcomes in patients undergoing cytoreductive surgery for advanced epithelial ovarian cancer. Gynecol Oncol. 2016 Oct 28:S0090-8258(16)31501-3. doi: 10.1016/j.ygyno.2016.10.027. Online ahead of print.
- Results publication: PubMed 32939254Bossy M, Nyman M, Madhuri TK, Tailor A, Chatterjee J, Butler-Manuel S, Ellis P, Feldheiser A, Creagh-Brown B. The need for post-operative vasopressor infusions after major gynae-oncologic surgery within an ERAS (Enhanced Recovery After Surgery) pathway. Perioper Med (Lond). 2020 Sep 7;9:26. doi: 10.1186/s13741-020-00158-0. eCollection 2020.
- Results publication: PubMed 24842135Pearse RM, Harrison DA, MacDonald N, Gillies MA, Blunt M, Ackland G, Grocott MP, Ahern A, Griggs K, Scott R, Hinds C, Rowan K; OPTIMISE Study Group. Effect of a perioperative, cardiac output-guided hemodynamic therapy algorithm on outcomes following major gastrointestinal surgery: a randomized clinical trial and systematic review. JAMA. 2014 Jun 4;311(21):2181-90. doi: 10.1001/jama.2014.5305.
- Results publication: PubMed 29779129Joosten A, Hafiane R, Pustetto M, Van Obbergh L, Quackels T, Buggenhout A, Vincent JL, Ickx B, Rinehart J. Practical impact of a decision support for goal-directed fluid therapy on protocol adherence: a clinical implementation study in patients undergoing major abdominal surgery. J Clin Monit Comput. 2019 Feb;33(1):15-24. doi: 10.1007/s10877-018-0156-x. Epub 2018 May 19.
Related trials for Ovarian Cancer
Active, not recruitingPhase 1/2
A Beta-only IL-2 ImmunoTherapY Study
Advanced Solid Tumor, Unresectable Solid Tumor
RecruitingPhase 2
WoO: Window of Opportunity Trial of Olaparib and Durvalumab in Histologically Proven EOC
Epithelial Ovarian Cancer
RecruitingPhase 2
Targeted Therapy Directed by Genetic Testing in Treating Patients With Locally Advanced or Advanced Solid Tumors, The ComboMATCH Screening Trial
Advanced Malignant Solid Neoplasm, Anatomic Stage III Breast Cancer AJCC v8
RecruitingPhase 1
A Study to Evaluate the Safety,Pharmacokinetics,Pharmacodynamics,and Efficacy of TJ037130 in Adult Participants With Advanced Solid Tumors
Solid Tumor, Metastatic Ovary Cancer
RecruitingObservational study
Polygenic Risk Scores and Multi-cancer Early Detection for Ovarian Cancer
Ovarian Cancer, BRCA Mutation
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.
Luciano Frassanito principal investigator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Assisted Fluid Management and Goal Directed Fluid Therapy (GDT) in people with Ovarian Cancer and Hemodynamic Instability, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS 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 2 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 11 May 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Luciano Frassanito, MD (+393475256158, luciano.frassanito@policlinicogemelli.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
TWA-MAP<65mmHg (time frame: Perioperative). The study lists 2 primary outcomes in all. 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 NCT07070973, which also lists 14 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 11 May 2026.