Clinical Trial: Intraoperative Anuric Episodes in Patients Undergoing Laparotomy

Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Observational

Official Title: Perioperative Relevance of Intraoperative Anuric Episodes Within a Goal-directed Haemodynamic Algorithm in Patients Undergoing Laparotomy Due to Epithelial Ovarian Cancer

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

Detailed Summary:
Sponsor: Claudia Spies

Current Primary Outcome: Exact measurement of urine production [ Time Frame: During the operation and in the 72-hour postoperative sample period ]

Exact measurement of urine production (number of anuric episodes anf duration of anuric episodes in minutes)


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Exact measurement of urine production [ Time Frame: During the operation and in the 72-hour postoperative sample period ]
    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 ]
    Parameters from blood sample
  • Hemodynamic parameters [ Time Frame: During the operation ]
  • Blood loss [ Time Frame: During the operation ]
  • Depth of Anesthesia [ Time Frame: During the operation ]
    Measuring depth of Anesthesia by Bispectral Index Monitoring
  • Organ dysfunctions [ Time Frame: During the operation and in the 72-hour postoperative sample period ]
  • Postoperative pain [ Time Frame: In the 72-hour postoperative sample period ]
  • Body weight development [ Time Frame: In the 72-hour postoperative sample period ]
  • Duration until fulfilment of hospital discharge criteria [ Time Frame: Participants will be followed for the duration of an expected average of 4 weeks ]
  • 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 ]
  • Quality of life and functional status [ Time Frame: Participants will be followed for the duration of hospital stay, an exspected average of 4 weeks ]
  • Inflammatory parameters [ Time Frame: In the 72-hour postoperative sample period ]
  • Amount of vasopressors [ Time Frame: During the operation and in the 72-hour postoperative sample period ]


Original Secondary Outcome: Same as current

Information By: Charite University, Berlin, Germany

Dates:
Date Received: September 24, 2012
Date Started: August 2016
Date Completion: September 2018
Last Updated: August 10, 2016
Last Verified: August 2016