NCT06164405

Brief Summary

In the present study the investigators aim to assess the changes of the arterial dP/dtmax induced by fluids and vasoactive drugs during abdominal surgery

Trial Health

87
On Track

Trial Health Score

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

Enrollment
88

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2024

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

December 1, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

December 11, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

February 1, 2024

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

March 10, 2025

Completed
Last Updated

April 8, 2025

Status Verified

April 1, 2025

Enrollment Period

1 year

First QC Date

December 1, 2023

Last Update Submit

April 4, 2025

Conditions

Intraoperative Hemodyamic Monitoring

Keywords

emodinamica

Outcome Measures

Primary Outcomes (1)

  • dp/dt fluids dependency

    measurement of dp/dtmax after fluid challenge

    intraoperative

Interventions

arterial dp/dtmaxDEVICE

to assess the variations of the arterial dp/dt max after drugs or fluids administration

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

surgical patients

You may qualify if:

  • patients scheduled for abdominal surgery informed consent acceptance

You may not qualify if:

  • BMI\> 30 Kg /m2;
  • Atrial Fibrillation;
  • Congestive heart failure with FE \<35% and/or NYHA≥3;
  • Severe known cardiac valve disease;
  • Emergency surgery
  • Shock or any acute conditions who required admission intensive care unit

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fondazione Policlinico Universitairo Agostino Gemelli

Roma, RM, 00148, Italy

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
24 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
medical doctor

Study Record Dates

First Submitted

December 1, 2023

First Posted

December 11, 2023

Study Start

February 1, 2024

Primary Completion

February 1, 2025

Study Completion

March 10, 2025

Last Updated

April 8, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)