Intraoperative Anuric Episodes in Patients Undergoing Laparotomy

August 10, 2016 updated by: Claudia Spies

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

Study Overview

Status

Withdrawn

Conditions

Study Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 13353
        • Department of Anesthesiology and Intensive Care Medicine, Campus Virchow Klinikum, Charité - Universitaetsmedizin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Ovarian cancer patients
Perioperative primary epithelial ovarian cancer patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
During the operation and in the 72-hour postoperative sample period

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
During the operation and in the 72-hour postoperative sample period
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
During the operation and in the 72-hour postoperative sample period
Hemodynamic parameters
Time Frame: During the operation
During the operation
Blood loss
Time Frame: During the operation
During the operation
Depth of Anesthesia
Time Frame: During the operation
Measuring depth of Anesthesia by Bispectral Index Monitoring
During the operation
Organ dysfunctions
Time Frame: During the operation and in the 72-hour postoperative sample period
During the operation and in the 72-hour postoperative sample period
Postoperative pain
Time Frame: In the 72-hour postoperative sample period
In the 72-hour postoperative sample period
Body weight development
Time Frame: In the 72-hour postoperative sample period
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
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
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
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
In the 72-hour postoperative sample period
Amount of vasopressors
Time Frame: During the operation and in the 72-hour postoperative sample period
During the operation and in the 72-hour postoperative sample period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Claudia Spies

Investigators

  • Study Director: Claudia Spies, MD, Prof., Department of Anesthesiology and Intensive Care Medicine CVK/CCM, Charité - University Berlin

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2016

Primary Completion (Anticipated)

June 1, 2018

Study Completion (Anticipated)

September 1, 2018

Study Registration Dates

First Submitted

September 24, 2012

First Submitted That Met QC Criteria

October 8, 2012

First Posted (Estimate)

October 10, 2012

Study Record Updates

Last Update Posted (Estimate)

August 11, 2016

Last Update Submitted That Met QC Criteria

August 10, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EPERIA

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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