Clinical trial NCT01703442: Intraoperative Anuric Episodes in Patients Undergoing Laparotomy
Official title: Perioperative Relevance of Intraoperative Anuric Episodes Within a Goal-directed Haemodynamic Algorithm in Patients Undergoing Laparotomy Due to Epithelial Ovarian Cancer
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Intraoperative Anuria
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2012-10-10
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Female patients being treated in the Department of Gynecology and Obstetrics, Campus Virchow Klinikum, Charité - Universitaetsmedizin Berlin.

Brief summary: 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


Eligibility criteria: 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

Primary outcomes:
measure: Exact measurement of urine production
timeFrame: During the operation and in the 72-hour postoperative sample period
Secondary outcomes:
measure: Exact measurement of urine production
timeFrame: During the operation and in the 72-hour postoperative sample period
measure: Biomarker for renal injury, Neutrophil gelatinase-associated lipocalin (NGAL) and creatinine
timeFrame: During the operation and in the 72-hour postoperative sample period
measure: Hemodynamic parameters
timeFrame: During the operation
measure: Blood loss
timeFrame: During the operation
measure: Depth of Anesthesia
timeFrame: During the operation
measure: Organ dysfunctions
timeFrame: During the operation and in the 72-hour postoperative sample period
measure: Postoperative pain
timeFrame: In the 72-hour postoperative sample period
measure: Body weight development
timeFrame: In the 72-hour postoperative sample period
measure: Duration until fulfilment of hospital discharge criteria
timeFrame: Participants will be followed for the duration of an expected average of 4 weeks
measure: ICU and hospital length of stay
timeFrame: Participants will be followed for the duration of intensive care unit stay and hospital stay, an expected average of 4 weeks
measure: Quality of life and functional status
timeFrame: Participants will be followed for the duration of hospital stay, an exspected average of 4 weeks
measure: Inflammatory parameters
timeFrame: In the 72-hour postoperative sample period
measure: Amount of vasopressors
timeFrame: During the operation and in the 72-hour postoperative sample period
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Department of Anesthesiology and Intensive Care Medicine, Campus Virchow Klinikum, Charité - Universitaetsmedizin
Study officials:
affiliation: Department of Anesthesiology and Intensive Care Medicine CVK/CCM, Charité - University Berlin
name: Claudia Spies, MD, Prof.
role: STUDY_DIRECTOR
References: