Intraoperative Anuric Episodes in Patients Undergoing Laparotomy

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified May 2014 by Charite University, Berlin, Germany
Sponsor:
Information provided by (Responsible Party):
Claudia Spies, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT01703442
First received: September 24, 2012
Last updated: May 14, 2014
Last verified: May 2014

September 24, 2012
May 14, 2014
January 2015
January 2016   (final data collection date for primary outcome measure)
Exact measurement of urine production [ Time Frame: During the operation and in the 72-hour postoperative sample period ] [ Designated as safety issue: No ]
Exact measurement of urine production (number of anuric episodes anf duration of anuric episodes in minutes)
Same as current
Complete list of historical versions of study NCT01703442 on ClinicalTrials.gov Archive Site
  • Exact measurement of urine production [ Time Frame: During the operation and in the 72-hour postoperative sample period ] [ Designated as safety issue: No ]
    Exact measurement of urine production (amount in milliliter)
  • Biomarker for renal injury, Neutrophil gelatinase-associated lipocalin (NGAL) and creatinine [ Time Frame: During the operation and in the 72-hour postoperative sample period ] [ Designated as safety issue: No ]
    Parameters from blood sample
  • Hemodynamic parameters [ Time Frame: During the operation ] [ Designated as safety issue: No ]
  • Blood loss [ Time Frame: During the operation ] [ Designated as safety issue: No ]
  • Depth of Anesthesia [ Time Frame: During the operation ] [ Designated as safety issue: No ]
    Measuring depth of Anesthesia by Bispectral Index Monitoring
  • Organ dysfunctions [ Time Frame: During the operation and in the 72-hour postoperative sample period ] [ Designated as safety issue: No ]
  • Postoperative pain [ Time Frame: In the 72-hour postoperative sample period ] [ Designated as safety issue: No ]
  • Body weight development [ Time Frame: In the 72-hour postoperative sample period ] [ Designated as safety issue: No ]
  • Duration until fulfilment of hospital discharge criteria [ Time Frame: Participants will be followed for the duration of an expected average of 4 weeks ] [ Designated as safety issue: No ]
  • ICU and hospital length of stay [ Time Frame: Participants will be followed for the duration of intensive care unit stay and hospital stay, an expected average of 4 weeks ] [ Designated as safety issue: No ]
  • Quality of life and functional status [ Time Frame: Participants will be followed for the duration of hospital stay, an exspected average of 4 weeks ] [ Designated as safety issue: No ]
  • Inflammatory parameters [ Time Frame: In the 72-hour postoperative sample period ] [ Designated as safety issue: No ]
  • Amount of vasopressors [ Time Frame: During the operation and in the 72-hour postoperative sample period ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Intraoperative Anuric Episodes in Patients Undergoing Laparotomy
Perioperative Relevance of Intraoperative Anuric Episodes Within a Goal-directed Haemodynamic Algorithm in Patients Undergoing Laparotomy Due to Epithelial Ovarian Cancer

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
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Female patients being treated in the Department of Gynecology and Obstetrics, Campus Virchow Klinikum, Charité - Universitaetsmedizin Berlin.

Intraoperative Anuria
Not Provided
Ovarian cancer patients
Perioperative primary epithelial ovarian cancer patients
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
25
February 2016
January 2016   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Contact: Claudia Spies, MD Prof. +49 30 450 551001 claudia.spies@charite.de
Germany
 
NCT01703442
EPERIA
No
Claudia Spies, Charite University, Berlin, Germany
Claudia Spies
Not Provided
Study Director: Claudia Spies, MD, Prof. Department of Anesthesiology and Intensive Care Medicine CVK/CCM, Charité - University Berlin
Charite University, Berlin, Germany
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP