Intraoperative Anuric Episodes in Patients Undergoing Laparotomy
Ключові слова
Анотація
Дати
| Востаннє перевірено: | 07/31/2016 |
| Перший поданий: | 09/23/2012 |
| Орієнтовна реєстрація подана: | 10/07/2012 |
| Опубліковано вперше: | 10/09/2012 |
| Останнє оновлення надіслано: | 08/09/2016 |
| Останнє оновлення опубліковано: | 08/10/2016 |
| Фактична дата початку навчання: | 07/31/2016 |
| Розрахункова дата первинного завершення: | 05/31/2018 |
| Розрахункова дата завершення дослідження: | 08/31/2018 |
Стан або захворювання
Фаза
Групи рук
| Рука | Втручання / лікування |
|---|---|
| Ovarian cancer patients Perioperative primary epithelial ovarian cancer patients |
Критерії прийнятності
| Вік, придатний для навчання | 18 Years До 18 Years |
| Стать, яка підходить для вивчення | Female |
| Метод відбору проб | Non-Probability Sample |
| Приймає здорових добровольців | Так |
| Критерії | Inclusion Criteria: - Offered patient information and written informed consent - Female patients aged greater than or equal to 18 years for cytoreductive surgery of a primary epithelial ovarian tumour Exclusion Criteria: - Patients with relapse Ovarian Cancer - Patients aged less than 18 years - Persons without the capacity to consent - Unability of German language use - Lacking willingness to save and hand out data within the study - Accommodation in an institution due to an official or judicial order - (Unclear) history of alcohol or substances disabuse - Coworker of the Charité - Advanced disease of the oesophagus or upper respiratory tract at the beginning of hospitalisation - Operation in the area of the oesophagus or nasopharynx within the last two months before participation in the study - Neurological or psychiatric disease at the beginning of hospitalisation - CHF (congestive heart failure) according to (New York Heart Association) classification - NYHA class IV at the beginning of hospitalisation - American Society of Anaesthesiologists (ASA) classification greater than IV - Renal insufficiency (dependency of haemodialysis) at the beginning of hospitalisation - Pulmonal oedema in thorax x-ray at the beginning of hospitalisation - History of intracranial hemorrhage within one year before participation in the study - Conditions following venous thrombosis within the last three years before study inclusion - Known allergies or hypersensitivity on colloidal, starch or gelatine infusion solutions - Diabetes mellitus with signs of severe neuropathy |
Результат
Заходи первинного результату
1. Exact measurement of urine production [During the operation and in the 72-hour postoperative sample period]
Заходи вторинного результату
1. Exact measurement of urine production [During the operation and in the 72-hour postoperative sample period]
2. Biomarker for renal injury, Neutrophil gelatinase-associated lipocalin (NGAL) and creatinine [During the operation and in the 72-hour postoperative sample period]
3. Hemodynamic parameters [During the operation]
4. Blood loss [During the operation]
5. Depth of Anesthesia [During the operation]
6. Organ dysfunctions [During the operation and in the 72-hour postoperative sample period]
7. Postoperative pain [In the 72-hour postoperative sample period]
8. Body weight development [In the 72-hour postoperative sample period]
9. Duration until fulfilment of hospital discharge criteria [Participants will be followed for the duration of an expected average of 4 weeks]
10. ICU and hospital length of stay [Participants will be followed for the duration of intensive care unit stay and hospital stay, an expected average of 4 weeks]
11. Quality of life and functional status [Participants will be followed for the duration of hospital stay, an exspected average of 4 weeks]
12. Inflammatory parameters [In the 72-hour postoperative sample period]
13. Amount of vasopressors [During the operation and in the 72-hour postoperative sample period]
