EVENT - Evaluation of the Influence of hTEE

Completed

• Conditions: Postoperative Heart Insufficiency

• Registration Number: NCT02046954
• Lead Sponsor: Charite University, Berlin, Germany

Brief Summary

Compromised tissue oxygenation during surgery may negatively influence patient outcome. Primary cause of insufficient tissue oxygenation is reduced cardiac output due to hypovolemia and/or reduced cardiac contractility. In cardiac surgery patients especially, postoperative pericardia effusion and/or tamponade may further compromise cardiac function. Today, hemodynamically instable patients are often monitored by means of pulmonal artery catheters or transpulmonary thermodilution. However, these methods only allow quantification of functional limitations. Underlying causes may be investigated by relatively recent technology through hemodynamically focussed transesophageal echocardiography (ClariTEE(R) ImaCor) that also provide the possibility of continuous monitoring. It has been reported that a training program consisting of six hours may enable physicians who are unexperienced in the field of echocardiography to apply this new method. Up to now, there is no evidence whether this methods is associated with improved postoperative outcome.

Therefore we hypothesize that continuous hemodynamically focussed transesophageal echocardiography positively influences patient outcome (primary hypothesis). Furthermore, its application may decrease hospital expenses (secondary hypothesis).

Detailed Description

Not available

Study Timeline

• Study Start: 2012-10
• Primary Completion: 2013-07
• Study Completion: 2013-07
• Status Verified: 2014-01
• Study First Submitted: 2014-01-19
• Study First Submitted QC: 2014-01-25
• Last Update Submitted: 2014-01-25
• Study First Posted: 2014-01-28
• Last Update Posted: 2014-01-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

• elective, cardiac surgery
• hemodynamic instability or placement of hTEE/PICCO (Pulse Contour Continuous Cardiac Output) /PAC (Pulmonary Arterial Catheter) within 12 hours of ICU admission

Exclusion Criteria

• pregnant/breastfeeding women

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cumulative dosage of catecholamine application	three days beginning upon placement of device

Secondary Outcome Measures

Name	Time	Method
duration of postoperative ventilation	first postoperative day until extubation (2 days on average)
incidence of renal failure	three days beginning upon placement of device (or icu admission in control patients, respectively)	analysis of creatinine plasma level
incidence of hemodialysis	three days beginning upon placement of device (or icu admission in control patients, respectively)
length of hospital stay	participants will be followed for the duration of hospital stay, an expected average of 3 weeks
in-hospital mortality	participants will be followed for the duration of hospital stay, an expected average of 3 weeks
cost of hospital stay	participants will be followed for the duration of hospital stay, an expected average of 3 weeks
degree and duration of other vasoactive substances	degree and duration of other vasoactive substances three days beginning upon placement of device (or icu admission in control patients, respectively)	i.e. epinephrine, levosimendan, dopamine, nitroglycerine, nitroprusside
fluid balance	day 1, 2 and 3, beginning upon placement of device (or icu admission in control patients, respectively)
degree and duration of lactate acidosis	degree and duration of other vasoactive substances three days beginning upon placement of device (or icu admission in control patients, respectively)	maximum lactate level, date/time of maximum lactate level, first date/time when lactate \<20

Trial Locations

Locations (1)

Charité Universitätsmedizin Berin; 🇩🇪 Berlin, Germany