Hemodynamic Instability
Conditions
Brief summary
This trial investigates the ability of our istitutional algorithm in maintaining a safe hemodynamics during abdominal aorta open surgery, in terms of limitation of intraoperative hypotension incidence
Detailed description
The present trial includes patients submitted to abdominal aorta open surgery. This type of procedure is very challenging for the hemodynamic management because of the operation per se (during which the surgeon clamp and unclamp the aorta with very significant hemodynamic variations) and because of the altered tone of the vessels due to the general vascular disease such a type of patients is suffering from. The aim of this study is to verify if the incidence of intraoperative hypotension in terms of severity, lasting and number of episodes, may be reduced by the application of a protocol of hemodynamic management. Primary endpoint: Global time spent in hypotension \<10%. Secondary Endpoints: 1. Time Weighted Average (TWA) of Area Under the Threshold \<0.4 mmHg 2. Incidence of hypotensive events/patient \< 8 (including the expected hypotensive events due to the aortic clamping and unclamping)
Interventions
OTHERIntraoperative fluids and vasoactive drugs management protocol
Limitation of hypotensive events during open surgery for abdominal aorta repair
Sponsors
Humanitas Clinical and Research Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Adults patients undergoing abdominal aorta open surgical repair
Exclusion criteria
* Emergent/urgent operation * Age \<18 years * Pregnancy * Intra-operative blood loss \> or = 3000ml
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Global time spent in hypotension <10% | Intraoperative period | Hypotension=mean arterial pressure \<65 mmHg for at least 1 minute |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time Weighted Average (TWA) of Area Under the Threshold <0.4 mmHg | Intraoperative period | The severity of hypotension during the whole intraoperative surgery |
| Incidence of hypotensive events/patient < 8 | Intraoperative period | including the expected hypotensive events due to the aortic clamping and unclamping |
Countries
Italy
Outcome results
None listed