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
  Purpose

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

Condition
Intraoperative Anuria

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Perioperative Relevance of Intraoperative Anuric Episodes Within a Goal-directed Haemodynamic Algorithm in Patients Undergoing Laparotomy Due to Epithelial Ovarian Cancer

Resource links provided by NLM:


Further study details as provided by Charite University, Berlin, Germany:

Primary Outcome Measures:
  • 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)


Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 25
Study Start Date: January 2015
Estimated Study Completion Date: February 2016
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
Ovarian cancer patients
Perioperative primary epithelial ovarian cancer patients

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01703442

Contacts
Contact: Claudia Spies, MD Prof. +49 30 450 551001 claudia.spies@charite.de

Locations
Germany
Department of Anesthesiology and Intensive Care Medicine, Campus Virchow Klinikum, Charité - Universitaetsmedizin Not yet recruiting
Berlin, Germany, 13353
Sub-Investigator: Aarne Feldheiser, MD         
Principal Investigator: Claudia Spies, MD, Prof.         
Sponsors and Collaborators
Claudia Spies
Investigators
Study Director: Claudia Spies, MD, Prof. Department of Anesthesiology and Intensive Care Medicine CVK/CCM, Charité - University Berlin
  More Information

No publications provided

Responsible Party: Claudia Spies, Department of Anesthesiology and Intensive Care Medicine CVK/CCM, Charite University, Berlin, Germany, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT01703442     History of Changes
Other Study ID Numbers: EPERIA
Study First Received: September 24, 2012
Last Updated: May 14, 2014
Health Authority: Germany: Ethics Commission

Additional relevant MeSH terms:
Anuria
Kidney Diseases
Urologic Diseases
Urination Disorders

ClinicalTrials.gov processed this record on July 22, 2014