Postoperative Heart InsufficiencyEVENTNCT02046954
EVENT - Evaluation of the Influence of hTEE
An observational study of Postoperative Heart Insufficiency, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Heart Insufficiency
- How many people
- 36 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2012to Jul 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing cardiac surgery followed by postoperative observation on an ICU of the anaesthesiology department of the Charité hospital
Who may be able to join
- 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
Who cannot join
- pregnant/breastfeeding women
Trial locations and contacts
1 site in 1 country.
Germany1 site
Charité Universitätsmedizin Berin
Berlin, State of Berlin, 10117
About this study
Official title: Retrospective Matched Pair Analyses for Evaluating the Influence of Hemodynamically Focussed Transesophageal Echocardiography (hTEE) on Postoperative Outcome in Cardiosurgery Patients
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).
- Conditions
- Postoperative Heart Insufficiency
- Keywords
- transesophageal echocardiography, tee, toe, cardiac surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Study group | Patients monitored with hemodynamically focussed transesophageal echocardiography (placement within 12 hours of ICU admission) | |
| Control Group | Patients receiving conventional monitoring (e.g. transpulmonary thermodilution) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative dosage of catecholamine application
Measured: three days beginning upon placement of device
Secondary outcomes (9)
degree and duration of other vasoactive substances
i.e. epinephrine, levosimendan, dopamine, nitroglycerine, nitroprusside
Measured: degree and duration of other vasoactive substances three days beginning upon placement of device (or icu admission in control patients, respectively)
fluid balance
Measured: day 1, 2 and 3, beginning upon placement of device (or icu admission in control patients, respectively)
degree and duration of lactate acidosis
maximum lactate level, date/time of maximum lactate level, first date/time when lactate <20
Measured: degree and duration of other vasoactive substances three days beginning upon placement of device (or icu admission in control patients, respectively)
duration of postoperative ventilation
Measured: first postoperative day until extubation (2 days on average)
incidence of renal failure
analysis of creatinine plasma level
Measured: three days beginning upon placement of device (or icu admission in control patients, respectively)
incidence of hemodialysis
Measured: three days beginning upon placement of device (or icu admission in control patients, respectively)
length of hospital stay
Measured: participants will be followed for the duration of hospital stay, an expected average of 3 weeks
in-hospital mortality
Measured: participants will be followed for the duration of hospital stay, an expected average of 3 weeks
cost of hospital stay
Measured: participants will be followed for the duration of hospital stay, an expected average of 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2014 (estimated)
- Study startOct 2012
- Primary completionJul 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Postoperative Heart InsufficiencyStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Sander, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02046954
- Sponsor's protocol ID
- EA1/249/13
- Acronym
- EVENT
- Status last verified
- Jan 2014
- First submitted
- 19 Jan 2014
- Last updated
- 28 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Cheitlin MD, Armstrong WF, Aurigemma GP, Beller GA, Bierman FZ, Davis JL, Douglas PS, Faxon DP, Gillam LD, Kimball TR, Kussmaul WG, Pearlman AS, Philbrick JT, Rakowski H, Thys DM, Antman EM, Smith SC Jr, Alpert JS, Gregoratos G, Anderson JL, Hiratzka LF, Faxon DP, Hunt SA, Fuster V, Jacobs AK, Gibbons RJ, Russell RO; ACC; AHA; ASE. ACC/AHA/ASE 2003 Guideline Update for the Clinical Application of Echocardiography: summary article. A report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (ACC/AHA/ASE Committee to Update the 1997 Guidelines for the Clinical Application of Echocardiography). J Am Soc Echocardiogr. 2003 Oct;16(10):1091-110. doi: 10.1016/S0894-7317(03)00685-0. No abstract available.
PubMed 14566308Pearse R, Dawson D, Fawcett J, Rhodes A, Grounds RM, Bennett ED. Early goal-directed therapy after major surgery reduces complications and duration of hospital stay. A randomised, controlled trial [ISRCTN38797445]. Crit Care. 2005;9(6):R687-93. doi: 10.1186/cc3887. Epub 2005 Nov 8.
PubMed 16356219Giglio MT, Marucci M, Testini M, Brienza N. Goal-directed haemodynamic therapy and gastrointestinal complications in major surgery: a meta-analysis of randomized controlled trials. Br J Anaesth. 2009 Nov;103(5):637-46. doi: 10.1093/bja/aep279.
PubMed 19837807Hamilton MA, Cecconi M, Rhodes A. A systematic review and meta-analysis on the use of preemptive hemodynamic intervention to improve postoperative outcomes in moderate and high-risk surgical patients. Anesth Analg. 2011 Jun;112(6):1392-402. doi: 10.1213/ANE.0b013e3181eeaae5. Epub 2010 Oct 21.
PubMed 20966436Gan TJ, Soppitt A, Maroof M, el-Moalem H, Robertson KM, Moretti E, Dwane P, Glass PS. Goal-directed intraoperative fluid administration reduces length of hospital stay after major surgery. Anesthesiology. 2002 Oct;97(4):820-6. doi: 10.1097/00000542-200210000-00012.
PubMed 12357146Futier E, Constantin JM, Petit A, Chanques G, Kwiatkowski F, Flamein R, Slim K, Sapin V, Jaber S, Bazin JE. Conservative vs restrictive individualized goal-directed fluid replacement strategy in major abdominal surgery: A prospective randomized trial. Arch Surg. 2010 Dec;145(12):1193-200. doi: 10.1001/archsurg.2010.275.
PubMed 21173294Dalfino L, Giglio MT, Puntillo F, Marucci M, Brienza N. Haemodynamic goal-directed therapy and postoperative infections: earlier is better. A systematic review and meta-analysis. Crit Care. 2011 Jun 24;15(3):R154. doi: 10.1186/cc10284.
PubMed 21702945Grocott MPW, Mythen MG, Gan TJ. Perioperative fluid management and clinical outcomes in adults. Anesth Analg. 2005 Apr;100(4):1093-1106. doi: 10.1213/01.ANE.0000148691.33690.AC.
PubMed 15781528Vincent JL, Rhodes A, Perel A, Martin GS, Della Rocca G, Vallet B, Pinsky MR, Hofer CK, Teboul JL, de Boode WP, Scolletta S, Vieillard-Baron A, De Backer D, Walley KR, Maggiorini M, Singer M. Clinical review: Update on hemodynamic monitoring--a consensus of 16. Crit Care. 2011 Aug 18;15(4):229. doi: 10.1186/cc10291.
PubMed 21884645Benjamin E, Griffin K, Leibowitz AB, Manasia A, Oropello JM, Geffroy V, DelGiudice R, Hufanda J, Rosen S, Goldman M. Goal-directed transesophageal echocardiography performed by intensivists to assess left ventricular function: comparison with pulmonary artery catheterization. J Cardiothorac Vasc Anesth. 1998 Feb;12(1):10-5. doi: 10.1016/s1053-0770(98)90048-9.
PubMed 9509350
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Matched Pair Analyses for Evaluating the Influence of Hemodynamically Focussed Transesophageal Echocardiography (hTEE) on Postoperative Outcome in Cardiosurgery Patients
- ClinicalTrials.gov ID
- NCT02046954
- Acronym / sponsor ID
- EVENT / EA1/249/13
- Conditions
- Postoperative Heart Insufficiency
- Keywords
- transesophageal echocardiography, tee, toe, cardiac surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 28 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group | – | –Patients monitored with hemodynamically focussed transesophageal echocardiography (placement within 12 hours of ICU admission) |
| Control Group | – | –Patients receiving conventional monitoring (e.g. transpulmonary thermodilution) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing cardiac surgery followed by postoperative observation on an ICU of the anaesthesiology department of the Charité hospital
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- pregnant/breastfeeding women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Cumulative dosage of catecholamine application
Time frame: three days beginning upon placement of device
9 secondary outcomes
degree and duration of other vasoactive substances
Time frame: degree and duration of other vasoactive substances three days beginning upon placement of device (or icu admission in control patients, respectively)
fluid balance
Time frame: day 1, 2 and 3, beginning upon placement of device (or icu admission in control patients, respectively)
degree and duration of lactate acidosis
Time frame: degree and duration of other vasoactive substances three days beginning upon placement of device (or icu admission in control patients, respectively)
duration of postoperative ventilation
Time frame: first postoperative day until extubation (2 days on average)
incidence of renal failure
Time frame: three days beginning upon placement of device (or icu admission in control patients, respectively)
incidence of hemodialysis
Time frame: three days beginning upon placement of device (or icu admission in control patients, respectively)
length of hospital stay
Time frame: participants will be followed for the duration of hospital stay, an expected average of 3 weeks
in-hospital mortality
Time frame: participants will be followed for the duration of hospital stay, an expected average of 3 weeks
cost of hospital stay
Time frame: participants will be followed for the duration of hospital stay, an expected average of 3 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2014.
- Background: PubMed 14566308Cheitlin MD, Armstrong WF, Aurigemma GP, Beller GA, Bierman FZ, Davis JL, Douglas PS, Faxon DP, Gillam LD, Kimball TR, Kussmaul WG, Pearlman AS, Philbrick JT, Rakowski H, Thys DM, Antman EM, Smith SC Jr, Alpert JS, Gregoratos G, Anderson JL, Hiratzka LF, Faxon DP, Hunt SA, Fuster V, Jacobs AK, Gibbons RJ, Russell RO; ACC; AHA; ASE. ACC/AHA/ASE 2003 Guideline Update for the Clinical Application of Echocardiography: summary article. A report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (ACC/AHA/ASE Committee to Update the 1997 Guidelines for the Clinical Application of Echocardiography). J Am Soc Echocardiogr. 2003 Oct;16(10):1091-110. doi: 10.1016/S0894-7317(03)00685-0. No abstract available.
- Background: PubMed 16356219Pearse R, Dawson D, Fawcett J, Rhodes A, Grounds RM, Bennett ED. Early goal-directed therapy after major surgery reduces complications and duration of hospital stay. A randomised, controlled trial [ISRCTN38797445]. Crit Care. 2005;9(6):R687-93. doi: 10.1186/cc3887. Epub 2005 Nov 8.
- Background: PubMed 19837807Giglio MT, Marucci M, Testini M, Brienza N. Goal-directed haemodynamic therapy and gastrointestinal complications in major surgery: a meta-analysis of randomized controlled trials. Br J Anaesth. 2009 Nov;103(5):637-46. doi: 10.1093/bja/aep279.
- Background: PubMed 20966436Hamilton MA, Cecconi M, Rhodes A. A systematic review and meta-analysis on the use of preemptive hemodynamic intervention to improve postoperative outcomes in moderate and high-risk surgical patients. Anesth Analg. 2011 Jun;112(6):1392-402. doi: 10.1213/ANE.0b013e3181eeaae5. Epub 2010 Oct 21.
- Background: PubMed 12357146Gan TJ, Soppitt A, Maroof M, el-Moalem H, Robertson KM, Moretti E, Dwane P, Glass PS. Goal-directed intraoperative fluid administration reduces length of hospital stay after major surgery. Anesthesiology. 2002 Oct;97(4):820-6. doi: 10.1097/00000542-200210000-00012.
- Background: PubMed 21173294Futier E, Constantin JM, Petit A, Chanques G, Kwiatkowski F, Flamein R, Slim K, Sapin V, Jaber S, Bazin JE. Conservative vs restrictive individualized goal-directed fluid replacement strategy in major abdominal surgery: A prospective randomized trial. Arch Surg. 2010 Dec;145(12):1193-200. doi: 10.1001/archsurg.2010.275.
- Background: PubMed 21702945Dalfino L, Giglio MT, Puntillo F, Marucci M, Brienza N. Haemodynamic goal-directed therapy and postoperative infections: earlier is better. A systematic review and meta-analysis. Crit Care. 2011 Jun 24;15(3):R154. doi: 10.1186/cc10284.
- Background: PubMed 15781528Grocott MPW, Mythen MG, Gan TJ. Perioperative fluid management and clinical outcomes in adults. Anesth Analg. 2005 Apr;100(4):1093-1106. doi: 10.1213/01.ANE.0000148691.33690.AC.
- Background: PubMed 21884645Vincent JL, Rhodes A, Perel A, Martin GS, Della Rocca G, Vallet B, Pinsky MR, Hofer CK, Teboul JL, de Boode WP, Scolletta S, Vieillard-Baron A, De Backer D, Walley KR, Maggiorini M, Singer M. Clinical review: Update on hemodynamic monitoring--a consensus of 16. Crit Care. 2011 Aug 18;15(4):229. doi: 10.1186/cc10291.
- Background: PubMed 9509350Benjamin E, Griffin K, Leibowitz AB, Manasia A, Oropello JM, Geffroy V, DelGiudice R, Hufanda J, Rosen S, Goldman M. Goal-directed transesophageal echocardiography performed by intensivists to assess left ventricular function: comparison with pulmonary artery catheterization. J Cardiothorac Vasc Anesth. 1998 Feb;12(1):10-5. doi: 10.1016/s1053-0770(98)90048-9.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Heart Insufficiency, run by Charite University, Berlin, Germany at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative dosage of catecholamine application (time frame: three days beginning upon placement of device). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02046954, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2014.