Intraoperative Anuric Episodes in Patients Undergoing Laparotomy

NCT01703442 | Withdrawn

• 1 other identifier: EPERIA
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Conditions

Intraoperative Anuria

Outcome Measures

Primary Outcomes (1)

• Exact measurement of urine production

  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 Outcomes (13)

• Exact measurement of urine production

  During the operation and in the 72-hour postoperative sample period

• Biomarker for renal injury, Neutrophil gelatinase-associated lipocalin (NGAL) and creatinine

  During the operation and in the 72-hour postoperative sample period

• Hemodynamic parameters

  During the operation

• Blood loss

  During the operation

• Depth of Anesthesia

  During the operation

Study Arms (1)

Ovarian cancer patients

Perioperative primary epithelial ovarian cancer patients

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Claudia Spies: lead

Study Sites (1)

Department of Anesthesiology and Intensive Care Medicine, Campus Virchow Klinikum, Charité - Universitaetsmedizin

Berlin, State of Berlin, 13353, Germany

Location

Study Officials

• Claudia Spies, MD, Prof.

  Department of Anesthesiology and Intensive Care Medicine CVK/CCM, Charité - University Berlin

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Department of Anesthesiology and Intensive Care Medicine CVK/CCM, Charite University, Berlin, Germany

Study Record Dates

• First Submitted: September 24, 2012
• First Posted: October 10, 2012
• Study Start: August 1, 2016
• Primary Completion: June 1, 2018
• Study Completion: September 1, 2018
• Last Updated: August 11, 2016

Record last verified: 2016-08

Locations

DE (1)