Intraoperative Anuria Clinical Trial
Official title:
Perioperative Relevance of Intraoperative Anuric Episodes Within a Goal-directed Haemodynamic Algorithm in Patients Undergoing Laparotomy Due to Epithelial Ovarian Cancer
| Verified date | August 2016 |
| Source | Charite University, Berlin, Germany |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Germany: Ethics Commission |
| Study type | Observational |
A single-center prospective observational study. This study examines urine flow and
haemodynamic parameters during abdominal surgery and analyses the association to
postoperative renal function and markers and to postoperative clinical outcome.
Primary hypothesis:
• Within a goal-directed haemodynamic protocol during gynecologic cancer surgery there are
phases of temporary anuria.
Secondary hypothesis:
- Perioperative anuric phases are directly associated to the postoperative increase of
NGAL (neutrophil gelatinase-associated lipocalin) and creatinine
- Perioperative renal dysfunction is directly associated to postoperative complications
and functional recovery of patients
- A response of urine flow to a standardized postoperative diuretic bolus can identify
patients who benefit from a pharmaceutical fluid mobilization
- Within a goal-directed haemodynamic protocol during gynaecologic cancer surgery, the
methods for the measurement of stroke volume of the heart differ
| Status | Withdrawn |
| Enrollment | 0 |
| Est. completion date | September 2018 |
| Est. primary completion date | June 2018 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 18 Years and older |
| Eligibility |
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 |
Observational Model: Cohort, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| Germany | Department of Anesthesiology and Intensive Care Medicine, Campus Virchow Klinikum, Charité - Universitaetsmedizin | Berlin |
| Lead Sponsor | Collaborator |
|---|---|
| Claudia Spies |
Germany,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Exact measurement of urine production | Exact measurement of urine production (number of anuric episodes anf duration of anuric episodes in minutes) | During the operation and in the 72-hour postoperative sample period | No |
| Secondary | Exact measurement of urine production | Exact measurement of urine production (amount in milliliter) | During the operation and in the 72-hour postoperative sample period | No |
| Secondary | Biomarker for renal injury, Neutrophil gelatinase-associated lipocalin (NGAL) and creatinine | Parameters from blood sample | During the operation and in the 72-hour postoperative sample period | No |
| Secondary | Hemodynamic parameters | During the operation | No | |
| Secondary | Blood loss | During the operation | No | |
| Secondary | Depth of Anesthesia | Measuring depth of Anesthesia by Bispectral Index Monitoring | During the operation | No |
| Secondary | Organ dysfunctions | During the operation and in the 72-hour postoperative sample period | No | |
| Secondary | Postoperative pain | In the 72-hour postoperative sample period | No | |
| Secondary | Body weight development | In the 72-hour postoperative sample period | No | |
| Secondary | Duration until fulfilment of hospital discharge criteria | Participants will be followed for the duration of an expected average of 4 weeks | No | |
| Secondary | 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 | No | |
| Secondary | Quality of life and functional status | Participants will be followed for the duration of hospital stay, an exspected average of 4 weeks | No | |
| Secondary | Inflammatory parameters | In the 72-hour postoperative sample period | No | |
| Secondary | Amount of vasopressors | During the operation and in the 72-hour postoperative sample period | No |