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NCT00966147 Clinical Trial

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

Hemodynamic Monitoring Clinical Trial

Official title:
Advanced Hemodynamic Monitoring for Goal-directed Hemodynamic Management During Radical Cystectomy

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT00966147
Other study ID # meroz01- HMO-CTIL
Secondary ID
Status Not yet recruiting
Phase N/A
First received August 25, 2009
Last updated August 25, 2009
Start date October 2009

Study information
Verified date July 2009
Source Hadassah Medical Organization
Contact Yuval Meroz, MD
Phone 97226777719
Email merozy@hadassah.org.il
Is FDA regulated No
Health authority Israel: Ministry of Health - Director General
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
Israel Hadassah Medical Organization, Jerusalem, Israel Jerusalem

Sponsors (1)
Lead Sponsor Collaborator
Hadassah Medical Organization

Country where clinical trial is conducted

Israel, 

Outcome
Type Measure Description Time frame Safety issue
Primary Mortality Hospital stay No
Secondary Morbidity Hospital stay No
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