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

August 25, 2009 updated by: Hadassah Medical Organization
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

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

  • Israel
      • Jerusalem, Israel, 91120
        • Hadassah Medical Organization, Jerusalem, Israel

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

All

Description

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

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

  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Lidco group
All patients monitored by the lidco system and treated to optimize oxygen delivery
Other: Increasing oxygen delivery .
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mortality
Time Frame: Hospital stay
Hospital stay

Secondary Outcome Measures

Outcome Measure
Time Frame
Morbidity
Time Frame: Hospital stay
Hospital stay

Collaborators and Investigators

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

Sponsor

Hadassah Medical Organization

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

October 1, 2009

Study Registration Dates

First Submitted

August 25, 2009

First Submitted That Met QC Criteria

August 25, 2009

First Posted (Estimate)

August 26, 2009

Study Record Updates

Last Update Posted (Estimate)

August 26, 2009

Last Update Submitted That Met QC Criteria

August 25, 2009

Last Verified

July 1, 2009

More Information

Terms related to this study

Other Study ID Numbers

  • meroz01- HMO-CTIL

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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