NCT07366164

Brief Summary

This study will investigate the impact of using an automated fluid management system on intraoperative fluid therapy in patients undergoing colorectal surgery. The aim is to evaluate whether automated guidance can optimize hemodynamic stability and reduce the incidence of arterial hypotension,

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
8mo left

Started Oct 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress48%
Oct 2025Jan 2027

First Submitted

Initial submission to the registry

September 10, 2025

Completed
21 days until next milestone

Study Start

First participant enrolled

October 1, 2025

Completed
4 months until next milestone

First Posted

Study publicly available on registry

January 26, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2027

Last Updated

January 26, 2026

Status Verified

January 1, 2026

Enrollment Period

8 months

First QC Date

September 10, 2025

Last Update Submit

January 16, 2026

Conditions

Fluid ManagementHemodynamic (MAP) Stability

Outcome Measures

Primary Outcomes (1)

  • amounts of fluids

    we registered and compared the amounts of administered fluids after surgery

    at the end of surgery

Study Arms (2)

treatment group

EXPERIMENTAL

fluid therpay fo this grioup will be giuded through the assisted fluid management system

Device: assisted fluid therapy

control group

NO INTERVENTION

patients belonging to this group will receive fluids following a standard hemodynamic protocol

Interventions

assisted fluid therapyDEVICE

for this intervention, fluids will be administered using an assisted fluid device

treatment group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- patients \>18 years old and ASA 3 scheduled for laparoscopic colorectal surgery

You may not qualify if:

  • Refusal of consent
  • Body Mass Index \> 35 kg/m2
  • urgent cases
  • pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fondazione Policlinico Universitario Policlinico Gemelli

Roma, RM, 00166, Italy

RECRUITING

Study Officials

  • andrea russo

    Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    PRINCIPAL INVESTIGATOR

Central Study Contacts

andrea russo, medical doctor

CONTACT

+393333926815russoandreamd@gmail.com

Paola Aceto, professor

CONTACT

paola.aceto@policlinicogemelli.it

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 10, 2025

First Posted

January 26, 2026

Study Start

October 1, 2025

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

January 1, 2027

Last Updated

January 26, 2026

Record last verified: 2026-01

Locations

IT(1)