Intraoperative Anuric Episodes in Patients Undergoing Lap... | NCT01703442

Studies
Intraoperative Anuric Episodes in Patients Undergoing Laparotomy

NCT01703442

Sponsor

Claudia Spies

Status

Withdrawn

Last Update Posted

Aug 11, 2016Estimated

Enrollment

0Actual

Phase

Not provided

Conditions

Intraoperative Anuria

Interventions

Not provided

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2016

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2016

Primary Completion Date

Jun 2018Estimated

Completion Date

Sep 2018Estimated

First Submitted Date

Sep 24, 2012

First Submission Date that Met QC Criteria

Oct 8, 2012

First Posted Date

Oct 10, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 10, 2016

Last Update Posted Date

Aug 11, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Label	Type	Description	Intervention Names
Ovarian cancer patients		Perioperative primary epithelial ovarian cancer patients

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Exact measurement of urine production	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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

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

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Anesthesiology and Intensive Care Medicine, Campus Virchow Klinikum, Charité - Universitaetsmedizin		Berlin	State of Berlin	13353	Germany