Ignite Creation Date:
2024-05-06 @ 8:22 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06351475
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-23
First Post:
2024-04-02
Brief Title:
Efficacy of Intraoperative Use of 20 Albumin Combined With Ringer Lactate Versus Ringer Lactate During Cytoreductive Surgery With Hyperthermic Intraperitoneal Chemotherapy
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
Evaluation de lefficacité du Remplissage Vasculaire Par de lALBUmine Humaine 20 Ringer Lactate comparé au Ringer Lactate Seul Chez Les Patients opérés Par cytoréduction Avec CHimiothérapie Intrapéritonéale hyPerthermique
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ALBUCHIP
Brief 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 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 11 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 mLkg 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 gL 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 136 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
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 11 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 mLkg 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 gL 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 136 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None