- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06164405
Arterial dP/dt Dependency on Loading Conditions (REABILITY)
March 19, 2024 updated by: RUSSO ANDREA, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
RESPONSE OF ARTERIAL dP/dt TO FLUIDS AND VASOACTIVE DRUGS DURING ABDOMINAL SURGERY: A PROSPECTIVE PILOT STUDY
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
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Estimated)
88
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: andrea russo
- Phone Number: +393333926815
- Email: russoandreamd@gmail.com
Study Locations
-
-
RM
-
Roma, RM, Italy, 00148
- Recruiting
- Fondazione Policlinico Universitairo Agostino Gemelli
-
Contact:
- Andrea Russo, MD
- Email: andrea.russo@policlinicogemelli.it
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Probability Sample
Study Population
surgical patients
Description
Inclusion Criteria:
patients scheduled for abdominal surgery informed consent acceptance
-
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
dp/dt fluids dependency
Time Frame: intraoperative
|
measurement of dp/dtmax after fluid challenge
|
intraoperative
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 1, 2024
Primary Completion (Estimated)
February 1, 2025
Study Completion (Estimated)
February 10, 2025
Study Registration Dates
First Submitted
December 1, 2023
First Submitted That Met QC Criteria
December 1, 2023
First Posted (Actual)
December 11, 2023
Study Record Updates
Last Update Posted (Actual)
March 20, 2024
Last Update Submitted That Met QC Criteria
March 19, 2024
Last Verified
December 1, 2023
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 6166
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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