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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2009 by Hadassah Medical Organization.
Recruitment status was:  Not yet recruiting
Sponsor:
Information provided by:
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT00966147
First received: August 25, 2009
Last updated: NA
Last verified: July 2009
History: No changes posted
  Purpose
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.

Condition Intervention
Radical Cystectomy
Perioperative Complications
Hemodynamic Monitoring
Other: Increasing oxygen delivery .

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Advanced Hemodynamic Monitoring for Goal-directed Hemodynamic Management During Radical Cystectomy

Further study details as provided by Hadassah Medical Organization:

Primary Outcome Measures:
  • Mortality [ Time Frame: Hospital stay ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Morbidity [ Time Frame: Hospital stay ] [ Designated as safety issue: No ]

Study Start Date: October 2009
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00966147

Locations
Israel
Hadassah Medical Organization, Jerusalem, Israel
Jerusalem, Israel, 91120
Sponsors and Collaborators
Hadassah Medical Organization
  More Information

Responsible Party: Yuval Meroz, MD, Hadassah Medical Organization, Jerusalem, Israel
ClinicalTrials.gov Identifier: NCT00966147     History of Changes
Other Study ID Numbers: meroz01- HMO-CTIL 
Study First Received: August 25, 2009
Last Updated: August 25, 2009
Health Authority: Israel: Ministry of Health - Director General

ClinicalTrials.gov processed this record on December 05, 2016