Intraoperative Anuric Episodes in Patients Undergoing Laparotomy

Withdrawn

• Conditions: Intraoperative Anuria

• Registration Number: NCT01703442
• Lead Sponsor: Claudia Spies

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 Description

Not available

Study Timeline

• Study First Submitted: 2012-09-24
• Study First Submitted QC: 2012-10-08
• Study First Posted: 2012-10-10
• Status Verified: 2016-08
• Study Start: 2016-08
• Last Update Submitted: 2016-08-10
• Last Update Posted: 2016-08-11
• Primary Completion: 2018-06
• Study Completion: 2018-09

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Exact measurement of urine production	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)

Secondary Outcome Measures

Name	Time	Method
Body weight development	In the 72-hour postoperative sample period
Exact measurement of urine production	During the operation and in the 72-hour postoperative sample period	Exact measurement of urine production (amount in milliliter)
Depth of Anesthesia	During the operation	Measuring depth of Anesthesia by Bispectral Index Monitoring
Biomarker for renal injury, Neutrophil gelatinase-associated lipocalin (NGAL) and creatinine	During the operation and in the 72-hour postoperative sample period	Parameters from blood sample
Quality of life and functional status	Participants will be followed for the duration of hospital stay, an exspected average of 4 weeks
Hemodynamic parameters	During the operation
Blood loss	During the operation
Organ dysfunctions	During the operation and in the 72-hour postoperative sample period
Duration until fulfilment of hospital discharge criteria	Participants will be followed for the duration of an expected average of 4 weeks
Amount of vasopressors	During the operation and in the 72-hour postoperative sample period
Postoperative pain	In the 72-hour postoperative sample period
ICU and hospital length of stay	Participants will be followed for the duration of intensive care unit stay and hospital stay, an expected average of 4 weeks
Inflammatory parameters	In the 72-hour postoperative sample period

Trial Locations

Locations (1)

Department of Anesthesiology and Intensive Care Medicine, Campus Virchow Klinikum, Charité - Universitaetsmedizin; 🇩🇪 Berlin, Germany