CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 142 enrolled
Drug / intervention
HPI based hemodynamic optimization algorithmother
Likely dose
Not stated in record
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Search/NCT04149314
NCT04149314N/ACompleted

PGDT With the "Hypotension Prediction Index" to Reduce the Number and Duration of Intraoperative Hypotension and the Incidence of Renal Failure in Patients Undergoing Lung Surgery

University of Giessen·interventional·Posted Nov 4, 2019·Updated Dec 1, 2023

In Brief

A clinical study evaluating HPI based hemodynamic optimization algorithm for Hypotension and 4 related conditions. Completed, enrolled 142 participants across 1 site.

Detailed Summary

The "Hypotension Prediction Index (HPI)" was established by the Edwards Lifescience Company (Irvine, California, USA) and is CE certified. As part of the Edwards Acumen Decision-Support-Software-Suite the HPI is supported by the minimal invasive FloTrac Sensor. The HPI displays the probability of an occurring hypotension. The software was established with the help of 20.000 analyzed patient events. If the upper limit of the HPI is reached, the software is alarming the treating physician 8. At the university hospital of Giessen HPI analyses are used in the daily clinical routine as well as for scientific purposes. Preliminary data of the HPI-I-Trial ("Influence of the Hypotension Prediction Index on the number and duration of intraoperative hypotension in primary hip-endoprothetic replacement", University Hospital of Giessen) included patients, which underwent hip-endoprothetic replacement surgery and revealed that the use of HPI with a goal directed therapy (GDT) protocol compared to standard care significantly reduced the incidence and duration of intraoperative hypotension. Therefore HPI with GDT might reduce the incidence of hypotension related complications in a sicker patient cohort. The aim of the study is to investigate whether a goal directed treatment according to the Hypotension Prediction Index compared to standard care can reduce the incidence of intraoperative hypotension in patients under single lung ventilation.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesGermany

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedNov 4, 2019
Enrollment StartNov 20, 2019
Primary CompletionJan 1, 2023
Study CompletionOct 31, 2023
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 6.7 years ago

Interventions

HPI based hemodynamic optimization algorithmother

Interventional patients will be treated by a HPI-based hemodynamic optimization protocol including HPI, Stroke volume, cardiac index and mean arterial pressure.