Heart Diseases Clinical Trial
Official title:
Perioperative Three Dimensional Right Ventricular Function
| NCT number | NCT02820727 |
| Other study ID # | AnTubingen-RV |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | October 2015 |
| Est. completion date | November 2016 |
| Verified date | June 2016 |
| Source | University Hospital Tuebingen |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
This study addresses the influence of anesthesia induction, ventilation and influence of cardiac surgical procedures and cardio-pulmonary-bypass on right ventricular function. Influence on patient outcome is also studied. Three dimensional echocardiography is applied.
| Status | Completed |
| Enrollment | 59 |
| Est. completion date | November 2016 |
| Est. primary completion date | November 2016 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 99 Years |
| Eligibility |
Inclusion Criteria: - informed consent given - cardiac surgical procedure - left sided cardiac surgery or bypass surgery, ascending aortic surgery, assist device implantation Exclusion Criteria: - pregnant patients - contraindication for transesophageal echocardiography |
| Country | Name | City | State |
|---|---|---|---|
| Germany | University Hospital Tubingen | Tubingen | BW |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital Tuebingen |
Germany,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Time on Intensive Care Unit (ICU) | Duration of ICU stay | up to 60 days | |
| Secondary | Time to hospital discharge | Hospital Outcome | up to 120 days | |
| Secondary | Catecholamine dosages | after anesthesia induction, end of surgery, 12h and 24h after intensive care unit (ICU) admission | up to 24 hours | |
| Secondary | Catecholamine free days | Catecholamine free days on ICU | up to 60 days | |
| Secondary | Hours on mechanical ventilation | Duration of mechanical ventilation | up to 1440 hours | |
| Secondary | Organ failure during ICU stay | Early organ failure (Lab tests: Creatinine, Bilirubin, Lactate, Thromboplastin Time) | up to 60 days |
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