Advanced Hemodynamic Monitoring for Goal-directed Hemodyn... | NCT00966147

Studies
Advanced Hemodynamic Monitoring for Goal-directed Hemodynamic Management During Radical Cystectomy

NCT00966147

Sponsor

Hadassah Medical Organization

Status

Unknown status

Last Update Posted

Aug 26, 2009Estimated

Enrollment

Not provided

Phase

Not Applicable

Conditions

Radical Cystectomy
Perioperative Complications
Hemodynamic Monitoring

Interventions

Increasing oxygen delivery .

Countries

Israel

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

Jul 2009

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2009

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Aug 25, 2009

First Submission Date that Met QC Criteria

Aug 25, 2009

First Posted Date

Aug 26, 2009Estimated

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 25, 2009

Last Update Posted Date

Aug 26, 2009Estimated

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

The purpose of this study is to determine whether increasing cardiac output by a combination of intravenous fluids and inotropic drugs can reduce mortality and morbidity in radical cystectomy operations.

Detailed Description

Not provided

Design Module

Study Type

Interventional

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 Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Lidco group	Experimental	All patients monitored by the lidco system and treated to optimize oxygen delivery	Other: Increasing oxygen delivery .

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Increasing oxygen delivery .	Other	The target is increasing oxygen delivery above 600ml/min/mr2 by either bolus of iv colloid or a continuous infusion of dopamine, dobutamine or noradrenaline. The fluids and drug administration will be directed and monitored by the lidco system and transesophageal echocardiography.

Measure	Description	Time Frame
Mortality		Hospital stay

Measure	Description	Time Frame
Morbidity		Hospital stay

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adults (>18yo) scheduled for elective radical cystectomy and ileal conduit formation

Exclusion Criteria:

Creatinine level above 200 mcg/dl
single functioning kidney
s/p kidney transplant
heart rhythm other than sinus
known allergy to lithium chloride
chronic lithium therapy
weight below 40 kg
mental or language problems that precludes obtaining informed consent

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Yuval Meroz, MD	Contact	97226777719		merozy@hadassah.org.il

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hadassah Medical Organization, Jerusalem, Israel		Jerusalem		91120	Israel