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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01650116
Other study ID # 2661P
Secondary ID
Status Recruiting
Phase N/A
First received July 24, 2012
Last updated November 19, 2014
Start date July 2012
Est. completion date December 2015

Study information

Verified date November 2014
Source Azienda Ospedaliera di Padova
Contact Paolo Feltracco, M.D.
Phone +393493410225
Email paolofeltracco@inwind.it
Is FDA regulated No
Health authority Italy: Ethics Committee
Study type Observational

Clinical Trial Summary

The purpose of this study is to verify any existing relationship between urinary parameters (such as excretion of sodium, chlorine, urinary partial CO2 pressure [PuCO2]) and general volemic indicators (such as PiCCO, ScvO2, O2 delivery) during liver transplant.


Recruitment information / eligibility

Status Recruiting
Enrollment 50
Est. completion date December 2015
Est. primary completion date December 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria:

- surgery for liver transplantation

- age 18-75

- ASA class I-III

Exclusion Criteria:

- age above 75 or under 18

- ASA class IV

- pre-existing renal failure

- pregnant patients

- patients unable to give written consent

Study Design

Observational Model: Case-Only, Time Perspective: Cross-Sectional


Related Conditions & MeSH terms

  • Hypovolemia
  • Hypovolemia During Liver Transplantation
  • Renal Hypoperfusion During Liver Transplantation

Locations

Country Name City State
Italy Azienda Ospedaliera di Padova Padova

Sponsors (1)

Lead Sponsor Collaborator
Azienda Ospedaliera di Padova

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary Determination of hemodynamic indicators (PiCCO, ScvO2, O2-delivery) and three urinary analytes (sodium, chloride, CO2 partial pressure) During the stay of the patient in the operating room (in average 8 hours) and the subsequent stay in the post-surgery intensive care unit (in average 5 days) No