Peritoneal NeoplasmsALBUCHIPNCT06351475
Efficacy of Intraoperative Use of 20% Albumin Combined With Ringer Lactate Versus Ringer Lactate During Cytoreductive Surgery With Hyperthermic Intraperitoneal Chemotherapy
A study testing Intra-operative albumin administration in people with Peritoneal Neoplasms and Hyperthermic Intraperitoneal Chemotherapy, run by Assistance Publique - Hôpitaux de Paris at 8 sites in France.
Trial summary
Introduction Cytoreductive surgery (CRS) with hyperthermic intraperitoneal chemotherapy (HIPEC) is considered as the standard of care for the treatment of peritoneal metastases. Cytoreductive surgery with HIPEC is characterized by large intra operative fluid shift secondary to surgical resection, peritoneal… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Peritoneal Neoplasms, Hyperthermic Intraperitoneal Chemotherapy, Intraoperative Care
- What is being tested?
- Intra-operative albumin administration
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 8 sitesFrance
- Study dates
- 3 Sep 2025to Oct 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female patients aged 18 years old and older
- Planned cytoreductive surgery with HIPEC for peritoneal carcinomatosis (from gynaecological or digestive origin)
- Patient volunteer for the study and provided written informed consent
- Patient affiliated to the French Health Insurance
Who cannot join
- Adults >75 years old
- Functional status rendering the patient ineligible for cytoreduction with CHIP (ECOG > 2 or Karnofsky index < 75)
- Pre-existing preoperative conditions affecting albuminemia (hepatic cirrhosis, nephrotic syndrome, exudative enteropathy, malnutrition)
- Severe preoperative hypoalbuminemia (albuminemia < 20 g/L)
- History of chronic left heart failure with reduced left ventricular ejection fraction (left ventricular ejection fraction < 40%)
- Patients at high risk of perioperative and postoperative pulmonary complications (atelectasis, significant pleural effusions)
Show all 19Show fewer
- Significant ascites with preoperative respiratory repercussions
- Uncontrolled diabetes (HbA1c > 8.5%)
- Allergy to exogenous human albumin and its excipients.
- Contraindication to the administration of Ringer's lactate (history of allergy)
- Hyperkalemia > 6.0 mmol/L
- Hypercalcemia (total calcium > 2.60 mmol/L)
- Chronic use of digitalis and hyperkalemic diuretics
- Pregnancy, breastfeeding
- Known preoperative renal failure (GFR < 30 mL/min/1.73m2 or extrarenal purification)
- Recent brain trauma < 6 months (traumatic, ischemic, or hemorrhagic)
- Participation in another interventional study involving human subjects or being in the exclusion period following a previous study involving human subjects, if applicable
- Patient deprived of liberty
- Patient under guardianship or curatorship
Trial locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
8 sites in 1 country
France8 sites, 8 recruiting
- Recruiting
Hôpital Lyon Sud Pierre Bénite
Lyon
Anne Li, 04 78 86 14 76 ext. +33, anne.li@chu-lyon.fr
- Recruiting
Institut régional du Cancer de Montpellier
Montpellier
Lana Zoric, 467618538 ext. +33, Lana.Zoric@icm.unicancer.fr
- Recruiting
La Pitié Salpetriere hospital
Paris, 75013
Alexandre Sitbon, 184827399 ext. +33, alexandre.sitbon@aphp.fr
- Recruiting
Lariboisière hospital
Paris
Nathalie Poirier, 1 49 95 68 43 ext. +33, nathalie.poirier@aphp.fr
- Recruiting
Saint Louis hospital
Paris
Arthur Moreau, 142499394 ext. +33, arthur.moreau@aphp.fr
- Recruiting
Robert Debré hospital
Reims
Ezechiel Bankole, 326788801 ext. +33, ebankole@chu-reims.fr
- Recruiting
Hôpital Hautepierre / UIC ARMO
Strasbourg
Valentina FAITOT, 388116768 ext. +33, valentina.faitot@chru-strasbourg.fr
- Recruiting
Gustave Roussy Institute
Villejuif
Stéphanie Suria, 142114437 ext. +33, Stephanie.SURIA@gustaveroussy.fr
About this study
Official title: Evaluation de l'efficacité du Remplissage Vasculaire Par de l'ALBUmine Humaine 20% + Ringer Lactate comparé au Ringer Lactate Seul Chez Les Patients opérés Par cytoréduction Avec CHimiothérapie Intrapéritonéale hyPerthermique
Introduction Cytoreductive surgery (CRS) with hyperthermic intraperitoneal chemotherapy (HIPEC) is considered as the standard of care for the treatment of peritoneal metastases. Cytoreductive surgery with HIPEC is characterized by large intra operative fluid shift secondary to surgical resection, peritoneal inflammation and capillary shifts, requesting high volume of intra operative fluid therapy. Previous studies found a strong association between intra operative hypovolemia or volume overload with post operative outcomes. Albumin as an intravenous fluid has been widely studied in critical ill patients, but evaluation of its efficacy during major surgery on post operative clinical outcomes are lacking. We hypothesize that a reduction of intra operative crystalloid volume infusion by using 20% albumin during CRS with HIPEC could improve patients' prognosis. The aim of this study will be to assess the efficacy of 20% albumin combined with Ringer Lactate versus Ringer Lactate for fluid therapy during CRS with HIPEC on post operative outcome at 28 day.
Methods and analysis The study protocol has been designed and written in accordance with the Prospective randomised, comparative, controlled, prospective, open-label, with parallel group and multicentre clinical trial.
Read more
Recruitment, randomisation and allocation Information on the study and screening of patients will be conducted during the consultation of anaesthesia (= selection visit), 2 months at 3 days before the surgery. Information notice and consent form will be delivered. The day before the surgery, anaesthesiologist who will conduct the pre anaesthetic visit will be able to include patients in the study (=inclusion visit). Randomisation will be done at the inclusion visit after information and signature of consent form of voluntary patients. A randomization number will be assigned. The 1:1 randomisation will be centralized via an online interface ensuring secret group assignment, and based on predefined randomisation lists with variable-size permutation blocks, stratified by center. Randomisation will be accomplished using a computer-generated random sequence.
Randomized Open, Blinded endpoint (PROBE) design. This study is a randomised, comparative, controlled, prospective, open-label, with parallel group and multicentre clinical trial.
Intervention
- 20% Albumin + Ringer Lactate group (intervention group) Per-operative fluid therapy consisting in Ringer Lactate combined with 20% albumin. Patients will receive a bolus of 3 mL/kg on one hour of 20% albumin from anaesthetic induction. Then, infusion of 20% albumin (100 mL, 20g) will be administered for each 1200 mL of vascular filling by Ringer Lactate. Dosage of intra operative albuminemia will be realized 2 hours after the end of the bolus or infusion to ensure albuminemia is within the target concentrations (35-45 g/L). Use of 20% albumin will be realized for the entire duration of the surgery and stopped at the end of the surgery.
- Control group Ringer Lactate for intra operative fluid management based on the latest scientific recommendations. As the the study is an open labelled randomized clinical trial, placebo use is not planned.
Outcome measures The primary outcome will be the Comprehensive Complication Index (CCI score) at day 28 after CRS with HIPEC. Secondary outcomes are mortality at day 28, CCI score at day 7, volume of intra operative and post operative (48h) post operative fluid therapy, cumulated incidence of surgical post operative complications, cumulated incidence of medical post operative complications, need for mechanical ventilation, renal replacement therapy between surgery and day 28, SOFA score variation between pre operative period and 48h after surgery, number of days alive out of intensive care unit and out of hospital until day 28
Sample size calculation To ensure a power of 80%, a number of patients 130 (65 patients by group) will be necessary with a reduction of 13.6 (SD 24) points of the CCI score at day 28 in the intervention group. Because of a risk of neoplastic evolution between anaesthetic consultation and randomisation (10% of early cancellation), a total of 146 patients (73 by group) will be included in the study.
Discussion In summary, ALBUCHIP study will be the first randomized clinical trial assessing efficacy of intraoperative use of 20% albumin combined with Ringer Lactate versus Ringer Lactate during CRS with HIPEC. Results yielded from this study will be helpful for vascular filling during CRS with HIPEC but, thanks to ancillary studies, to improve pathophysiological understanding of this surgery.
- Conditions
- Peritoneal Neoplasms, Hyperthermic Intraperitoneal Chemotherapy, Intraoperative Care, Fluid Therapy, Postoperative Complications
- Being tested
- Intra-operative albumin administration, Control
- Keywords
- Cytoreductive surgery, Hyperthermic intraperitoneal chemotherapy, Albumin administration, Fluid therapy, Post operative prognosis, Randomized clinical trial, Open label clinical trial
- Medical subject headings
- Peritoneal Neoplasms, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intra-operative albumin administrationOther
Patients randomized in the intervention group (20% albumin + Ringer Lactate) will receive, during cytoreductive surgery with HIPEC, fluid therapy consisting in Ringer Lactate (based on a fluid management protocol specifically set up for the study, and based on latest recommendations) combined with 20% albumin. Patients randomized in the intervention group will receive a bolus of 3 mL/kg on one hour of 20% albumin from anesthetic induction . Dosage of albuminemia will be done 2 hours after the end of the bolus (target of 35-45 g/L of intra operative albuminemia). Then, infusion of 20% albumin (100 mL, 20g) will be administered for each 1200 mL of vascular filling by Ringer Lactate. Dosage of intra operative albuminemia will be realized 2 hours after the end of the bolus or infusion to ensure albuminemia is within the target concentrations (35-45 g/L). Use of 20% albumin will be realized for the entire duration of the surgery and stopped at the end of the surgery.
ControlOther
Ringer lactate
| Study group | Role | What they receive |
|---|---|---|
| 20% Albumin + Ringer Lactate group | Experimental | Per-operative fluid therapy consisting in Ringer Lactate combined with 20% albumin. Patients will receive a bolus of 3 mL/kg on one hour of 20% albumin from anaesthetic induction. Then, infusion of 20% albumin (100 mL, 20g) will be administered for each 1200 mL of vascular filling by Ringer Lactate. Dosage of intra operative albuminemia will be realized 2 hours after the end of the bolus or infusion to ensure albuminemia is within the target concentrations (35-45 g/L). Use of 20% albumin will be realized for the entire duration of the surgery and stopped at the end of the surgery. Receives: Other: Intra-operative albumin administration |
| Control group | Active comparator | Ringer Lactate for intra operative fluid management based on the latest scientific recommendations. As the the study is an open labelled randomized clinical trial, placebo use is not planned. Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comprehensive Complication Index score
The Comprehensive Complication Index (CCI) is a score ranging from 0 to 100, calculated using all complications and their treatment after abdominal surgery.
The CCI is that it is a linear scale ranging from 0 to 100, where 100 represents death
Measured: At day 28
Secondary outcomes (15)
Comprehensive Complication Index score
The Comprehensive Complication Index (CCI) is a score ranging from 0 to 100, calculated using all complications and their treatment after abdominal surgery.
The CCI is that it is a linear scale ranging from 0 to 100, where 100 represents death
Measured: At day 7
Volume of intra operative and post operative fluid therapy
Measured: 48 hours after surgery
Cumulative incidence of surgical post operative complications
Measured: Up to day 28
Incidence of infectious complications
Measured: Up to day 28
Number of days under mechanical ventilation outside the operating room
Between surgery and day 28
Measured: Up to day 28
Number of days under renal replacement therapy
Between surgery and day 28
Measured: Up to day 28
Sequential organ failure assessment (SOFA) score variation
Between pre operative period and 48h after surgery
Measured: 48 hours after surgery
Number of days alive out of intensive care unit
Measured: Up to day 28
Number of days alive out of hospital
Measured: Up to day 28
Incidence of medical complications
Measured: Up to day 28
Cumulative incidence of death in intensive care unit
Measured: Up to day 28
Cumulative incidence of death in hospital
Measured: Up to day 28
SOFA score
Sequential Organ Failure Assessment Score varies from 0 to 4 and permit to assess organ failure. A higher score indicates better neurological function
Measured: At day 28
Number of days under vasopressors
Measured: Up to day 28
Proportion of patients with allergic complications to albumin
Measured: At day 133
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2024
- Study start3 Sep 2025
- Primary completionOct 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Peritoneal NeoplasmsStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06351475
- Sponsor's protocol ID
- APHP230864
- Acronym
- ALBUCHIP
- Status last verified
- Nov 2025
- First submitted
- 2 Apr 2024
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Deniau B, Moreau A, Monsel A, Faitot V, Pottecher J, Zoric L, Suria S, Bankole E, Michelet D, Poirier N, Plaud B, Chaix C, Biard L, Depret F. Efficacy of intraoperative use of 20% albumin in combination with Ringer's lactate versus Ringer's lactate during cytoreductive surgery with hyperthermic intraperitoneal chemotherapy: protocol for a randomised controlled, open-label clinical trial (ALBUCHIP trial). BMJ Open. 2026 Apr 27;16(4):e109391. doi: 10.1136/bmjopen-2025-109391.
PubMed 42044958
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation de l'efficacité du Remplissage Vasculaire Par de l'ALBUmine Humaine 20% + Ringer Lactate comparé au Ringer Lactate Seul Chez Les Patients opérés Par cytoréduction Avec CHimiothérapie Intrapéritonéale hyPerthermique
- ClinicalTrials.gov ID
- NCT06351475
- Acronym / sponsor ID
- ALBUCHIP / APHP230864
- Conditions
- Peritoneal Neoplasms, Hyperthermic Intraperitoneal Chemotherapy, Intraoperative Care, Fluid Therapy, Postoperative Complications
- Keywords
- Cytoreductive surgery, Hyperthermic intraperitoneal chemotherapy, Albumin administration, Fluid therapy, Post operative prognosis, Randomized clinical trial, Open label clinical trial
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 3 Sep 2025 (actual)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 8 Apr 2024 (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.
Introduction Cytoreductive surgery (CRS) with hyperthermic intraperitoneal chemotherapy (HIPEC) is considered as the standard of care for the treatment of peritoneal metastases. Cytoreductive surgery with HIPEC is characterized by large intra operative fluid shift secondary to surgical resection, peritoneal inflammation and capillary shifts, requesting high volume of intra operative fluid therapy. Previous studies found a strong association between intra operative hypovolemia or volume overload with post operative outcomes. Albumin as an intravenous fluid has been widely studied in critical ill patients, but evaluation of its efficacy during major surgery on post operative clinical outcomes are lacking. We hypothesize that a reduction of intra operative crystalloid volume infusion by using 20% albumin during CRS with HIPEC could improve patients' prognosis. The aim of this study will be to assess the efficacy of 20% albumin combined with Ringer Lactate versus Ringer Lactate for fluid therapy during CRS with HIPEC on post operative outcome at 28 day.
Methods and analysis The study protocol has been designed and written in accordance with the Prospective randomised, comparative, controlled, prospective, open-label, with parallel group and multicentre clinical trial.
Recruitment, randomisation and allocation Information on the study and screening of patients will be conducted during the consultation of anaesthesia (= selection visit), 2 months at 3 days before the surgery. Information notice and consent form will be delivered. The day before the surgery, anaesthesiologist who will conduct the pre anaesthetic visit will be able to include patients in the study (=inclusion visit). Randomisation will be done at the inclusion visit after information and signature of consent form of voluntary patients. A randomization number will be assigned. The 1:1 randomisation will be centralized via an online interface ensuring secret group assignment, and based on predefined randomisation lists with variable-size permutation blocks, stratified by center. Randomisation will be accomplished using a computer-generated random sequence.
Randomized Open, Blinded endpoint (PROBE) design. This study is a randomised, comparative, controlled, prospective, open-label, with parallel group and multicentre clinical trial.
Intervention
- 20% Albumin + Ringer Lactate group (intervention group) Per-operative fluid therapy consisting in Ringer Lactate combined with 20% albumin. Patients will receive a bolus of 3 mL/kg on one hour of 20% albumin from anaesthetic induction. Then, infusion of 20% albumin (100 mL, 20g) will be administered for each 1200 mL of vascular filling by Ringer Lactate. Dosage of intra operative albuminemia will be realized 2 hours after the end of the bolus or infusion to ensure albuminemia is within the target concentrations (35-45 g/L). Use of 20% albumin will be realized for the entire duration of the surgery and stopped at the end of the surgery.
- Control group Ringer Lactate for intra operative fluid management based on the latest scientific recommendations. As the the study is an open labelled randomized clinical trial, placebo use is not planned.
Outcome measures The primary outcome will be the Comprehensive Complication Index (CCI score) at day 28 after CRS with HIPEC. Secondary outcomes are mortality at day 28, CCI score at day 7, volume of intra operative and post operative (48h) post operative fluid therapy, cumulated incidence of surgical post operative complications, cumulated incidence of medical post operative complications, need for mechanical ventilation, renal replacement therapy between surgery and day 28, SOFA score variation between pre operative period and 48h after surgery, number of days alive out of intensive care unit and out of hospital until day 28
Sample size calculation To ensure a power of 80%, a number of patients 130 (65 patients by group) will be necessary with a reduction of 13.6 (SD 24) points of the CCI score at day 28 in the intervention group. Because of a risk of neoplastic evolution between anaesthetic consultation and randomisation (10% of early cancellation), a total of 146 patients (73 by group) will be included in the study.
Discussion In summary, ALBUCHIP study will be the first randomized clinical trial assessing efficacy of intraoperative use of 20% albumin combined with Ringer Lactate versus Ringer Lactate during CRS with HIPEC. Results yielded from this study will be helpful for vascular filling during CRS with HIPEC but, thanks to ancillary studies, to improve pathophysiological understanding of this surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 20% Albumin + Ringer Lactate group | Experimental | Other: Intra-operative albumin administrationPer-operative fluid therapy consisting in Ringer Lactate combined with 20% albumin. Patients will receive a bolus of 3 mL/kg on one hour of 20% albumin from anaesthetic induction. Then, infusion of 20% albumin (100 mL, 20g) will be administered for each 1200 mL of vascular filling by Ringer Lactate. Dosage of intra operative albuminemia will be realized 2 hours after the end of the bolus or infusion to ensure albuminemia is within the target concentrations (35-45 g/L). Use of 20% albumin will be realized for the entire duration of the surgery and stopped at the end of the surgery. |
| Control group | Active comparator | Other: ControlRinger Lactate for intra operative fluid management based on the latest scientific recommendations. As the the study is an open labelled randomized clinical trial, placebo use is not planned. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male and female patients aged 18 years old and older
- Planned cytoreductive surgery with HIPEC for peritoneal carcinomatosis (from gynaecological or digestive origin)
- Patient volunteer for the study and provided written informed consent
- Patient affiliated to the French Health Insurance
Key exclusion criteria (19 listed)
- Adults >75 years old
- Functional status rendering the patient ineligible for cytoreduction with CHIP (ECOG > 2 or Karnofsky index < 75)
- Pre-existing preoperative conditions affecting albuminemia (hepatic cirrhosis, nephrotic syndrome, exudative enteropathy, malnutrition)
- Severe preoperative hypoalbuminemia (albuminemia < 20 g/L)
- History of chronic left heart failure with reduced left ventricular ejection fraction (left ventricular ejection fraction < 40%)
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 |
|---|---|---|
| Intra-operative albumin administrationPatients randomized in the intervention group (20% albumin + Ringer Lactate) will receive, during cytoreductive surgery with HIPEC, fluid therapy consisting in Ringer Lactate (based on a fluid management protocol specifically set up for the study, and based on latest recommendations) combined with 20% albumin. Patients randomized in the intervention group will receive a bolus of 3 mL/kg on one hour of 20% albumin from anesthetic induction . Dosage of albuminemia will be done 2 hours after the end of the bolus (target of 35-45 g/L of intra operative albuminemia). Then, infusion of 20% albumin (100 mL, 20g) will be administered for each 1200 mL of vascular filling by Ringer Lactate. Dosage of intra operative albuminemia will be realized 2 hours after the end of the bolus or infusion to ensure albuminemia is within the target concentrations (35-45 g/L). Use of 20% albumin will be realized for the entire duration of the surgery and stopped at the end of the surgery. | Other | 20% Albumin + Ringer Lactate group |
| ControlRinger lactate | Other | Control group |
Primary outcome
Comprehensive Complication Index score
Time frame: At day 28
The Comprehensive Complication Index (CCI) is a score ranging from 0 to 100, calculated using all complications and their treatment after abdominal surgery. The CCI is that it is a linear scale ranging from 0 to 100, where 100 represents death
15 secondary outcomes
Comprehensive Complication Index score
Time frame: At day 7
Volume of intra operative and post operative fluid therapy
Time frame: 48 hours after surgery
Cumulative incidence of surgical post operative complications
Time frame: Up to day 28
Incidence of infectious complications
Time frame: Up to day 28
Number of days under mechanical ventilation outside the operating room
Time frame: Up to day 28
Number of days under renal replacement therapy
Time frame: Up to day 28
Sequential organ failure assessment (SOFA) score variation
Time frame: 48 hours after surgery
Number of days alive out of intensive care unit
Time frame: Up to day 28
Number of days alive out of hospital
Time frame: Up to day 28
Incidence of medical complications
Time frame: Up to day 28
Cumulative incidence of death in intensive care unit
Time frame: Up to day 28
Cumulative incidence of death in hospital
Time frame: Up to day 28
SOFA score
Time frame: At day 28
Number of days under vasopressors
Time frame: Up to day 28
Proportion of patients with allergic complications to albumin
Time frame: At day 133
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 29 Sep 2026.
- Derived from this study: PubMed 42044958Deniau B, Moreau A, Monsel A, Faitot V, Pottecher J, Zoric L, Suria S, Bankole E, Michelet D, Poirier N, Plaud B, Chaix C, Biard L, Depret F. Efficacy of intraoperative use of 20% albumin in combination with Ringer's lactate versus Ringer's lactate during cytoreductive surgery with hyperthermic intraperitoneal chemotherapy: protocol for a randomised controlled, open-label clinical trial (ALBUCHIP trial). BMJ Open. 2026 Apr 27;16(4):e109391. doi: 10.1136/bmjopen-2025-109391.
- 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.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intra-operative albumin administration in people with Peritoneal Neoplasms and Hyperthermic Intraperitoneal Chemotherapy, run by Assistance Publique - Hôpitaux de Paris at 8 sites in France.
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 4 inclusion and 19 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 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in France. 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 Arthur Moreau, Dr (142499394 ext. +33, arthur.moreau@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comprehensive Complication Index score (time frame: At day 28). 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 NCT06351475, which also lists 1 linked publication.
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 29 Sep 2026.