NCT00966147

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 25, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 26, 2009

Completed
1 month until next milestone

Study Start

First participant enrolled

October 1, 2009

Completed
Last Updated

August 26, 2009

Status Verified

July 1, 2009

First QC Date

August 25, 2009

Last Update Submit

August 25, 2009

Conditions

Radical CystectomyPerioperative ComplicationsHemodynamic Monitoring

Outcome Measures

Primary Outcomes (1)

  • Mortality

    Hospital stay

Secondary Outcomes (1)

  • Morbidity

    Hospital stay

Study Arms (1)

Lidco group

EXPERIMENTAL

All patients monitored by the lidco system and treated to optimize oxygen delivery

Other: Increasing oxygen delivery .

Interventions

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.

Lidco group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hadassah Medical Organization, Jerusalem, Israel

Jerusalem, 91120, Israel

Location

Central Study Contacts

Yuval Meroz, MD

CONTACT

97226777719merozy@hadassah.org.il

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 25, 2009

First Posted

August 26, 2009

Study Start

October 1, 2009

Last Updated

August 26, 2009

Record last verified: 2009-07

Locations

IL(1)