Acute Hemodynamic Changes During Paracentesis
December 14, 2016 updated by: Joachim Saur, Universitätsmedizin Mannheim
The aim of our study was to evaluate hemodynamic changes during routine paracentesis in tense ascites using non-invasive inert gas rebreathing.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
36
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
18 years to 80 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients undergoing routine therapeutic paracentesis due to refractory tense ascites at a university hospital.
Description
Inclusion Criteria:
- refractory tense ascites with indication for therapeutic paracentesis
Exclusion Criteria:
- pregnancy
- inability to give inform consent
- inability to perform rebreathing maneuver
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
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Patients with refractory tense ascites
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
change in cardiac output
Time Frame: 30 minutes
|
prior to and after paracentesis
|
30 minutes
|
|
change in systemic vascular resistance
Time Frame: 30 minutes
|
prior to and after paracentesis
|
30 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
June 1, 2012
Primary Completion (ACTUAL)
November 1, 2013
Study Completion (ACTUAL)
November 1, 2013
Study Registration Dates
First Submitted
December 14, 2016
First Submitted That Met QC Criteria
December 14, 2016
First Posted (ESTIMATE)
December 19, 2016
Study Record Updates
Last Update Posted (ESTIMATE)
December 19, 2016
Last Update Submitted That Met QC Criteria
December 14, 2016
Last Verified
December 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IGR-paracentesis
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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.