EUCTR2013-005282-39-IT
Active, not recruiting
Phase 1
Effects of high Intra-abdominal pressure on tissue diffusion and pharmacokinectics of cisplatin during HIPEC
Fondazione IRCCS Istituto Nazionale dei Tumori di Milano0 sites38 target enrollmentJanuary 28, 2014
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Fondazione IRCCS Istituto Nazionale dei Tumori di Milano
- Enrollment
- 38
- Status
- Active, not recruiting
- Last Updated
- 8 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Histological diagnosis of primary peritoneal carcinomatosis from
- •colorectal origin orpseudomyxoma peritonei;
- •2\. Patients submitted to complete cytoreduction with residual tumor
- •3\. Patients at the end of cytoreduction should present the laboratorial
- •and hemodynamic parameters set as followings: Mean arterial pressure \> 65
- •mmHg, Heart rate: \< 100 bpm, Central venous pressure \> 4mmHg, Cardiac index \>
- •2\.2, SvcO2 \> 72%, and haemoglobin \> 8,0 gr/dl.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
Exclusion Criteria
- •age\>75 years, patients that does not give informed consent
Outcomes
Primary Outcomes
Not specified
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