Surgery Clinical Trial
Official title:
Influence of the "Hypotension Probability Index" on the Number and Duration of Intraoperative Hypotension in Primary Hip Endoprosthetic Replacement
NCT number | NCT03663270 |
Other study ID # | 09/17 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | June 22, 2017 |
Est. completion date | October 30, 2018 |
Verified date | July 2019 |
Source | University of Giessen |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The aim of the study is to investigate the value of the Hypotension Probability Index in reducing intraoperative hypotension in patients with primary hip replacement. The measurement of the blood pressure was and is of great interest for the treating physician/anesthesiologist to optimize the peri- and postoperative patients outcome. The non-invasive measurement can scale the blood pressure but not from heartbeat-to-heartbeat, what results in a loss of information. The invasive measurement by a placed catheter in an artery shows the blood pressure with information about the pulse wave form, the ascending angle, and makes it possible to detect hemodynamic changes in a way the non-invasive blood pressure measurement is lacking. The additional informations of the monitoring and a
Status | Completed |
Enrollment | 50 |
Est. completion date | October 30, 2018 |
Est. primary completion date | June 30, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Patients undergoing hip-replacement - General anesthesia - Age = 18 years Exclusion Criteria: - Participation in another (interventional) study - Pregnancy and nursing mothers - Surgery without controlled ventilation - ASA > III - Contraindication for invasive blood pressure monitoring - Renal insufficiency KDIGO Stadium = 2 - Coagulation disorder |
Country | Name | City | State |
---|---|---|---|
Germany | Michael Sander | Gießen |
Lead Sponsor | Collaborator |
---|---|
University of Giessen |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Episode of hypotension | The aim of the study is to investigate whether a goal directed treatment according to the Hypotension Probability Index compared to standard care can reduce the incidence of intraoperative hypotension in patients with hip-replacement. As primary endpoints frequency (n)/h, absolute and relative duration (t [min]/% of total anesthesia time) of intraoperative hypotension were defined for this study. | up to 18 months | |
Secondary | Changes of fluid management | Amount of of intravenous fluids (ml of crystalloids, ml of colloids) | up to 18 months | |
Secondary | Changes of catecholamine management | Dosage of vasopressors and inotropes (µg) | up to 18 months |
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