search  
 


Home

Who are we?

Why
register?


Signup for
registration


Online registration

Log in to register
your trial


Search a trial

NRT en CCMO

Contact

NEDERLANDS





MetaRegister
van CCT (UK)


ISRCTN-Register
van CCT (UK)


Hemodynamic monitoring during HIPEC procedures


- candidate number22332
- NTR NumberNTR5249
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR11-jun-2015
- Secondary IDs 2015-1793 CMO Regio Arnhem-Nijmegen
- Public TitleHemodynamic monitoring during HIPEC procedures
- Scientific TitleHEmodynamische MOnitoring tijdens HIPEC procedures.
- ACRONYMHEMOHIP- studie
- hypothesisNon invasive hemodynamic monitoring is as good as invasive monitoring
- Healt Condition(s) or Problem(s) studiedHemodynamic Monitoring, SIRS, Surgery
- Inclusion criteriaPatients undergoing a HIPEC procedure and receive hemodynamic monitoring with the TPTD through PiCCO monitoring.
Patients older than 18 years
- Exclusion criteria- Severe tricupid or aortic regurgitation
- Severe peripheral vascular dissease
- mec approval receivedyes
- multicenter trialno
- randomisedno
- group[default]
- Type[default]
- Studytypeobservational
- planned startdate 1-nov-2015
- planned closingdate1-nov-2016
- Target number of participants25
- InterventionsComparison:
invasive hemodynamic monitoring (PICCO) vs less invasive monitoring (ProaQt and FloTrac) and non invasive monitoring (nexfin/clearsight)
- Primary outcomeDetermining the reliability of the less invasive hemodynamic measurement methods with respect to the reference measuring method (= TPTD), for a variety of pre-defined moments peri and post OK.
Comparison absolute numbers; TPTD vs less invasive Cardiac Output (bias, precision, limits of agreement, percentage of error; Bland Altman plot). By time (T1 ... .T9), and all paired data points corrected for "repeated measurements".
- Secondary outcomeROC curve to detect SV change > 15%
- TimepointsT = 0, synchronization clocks, calibrate CCO PiCCO using TPTD,
T2 and T3 measurement in the middle of debulking period;
T4 start HIPEC;
T5 middle HIPEC;
T6 end HIPEC;
T7 end OK;
T8 and T9 on the IC around 6 and 12 hours post operative
- Trial web site
- status[default]
- CONTACT FOR PUBLIC QUERIES Cor Slagt
- CONTACT for SCIENTIFIC QUERIES Cor Slagt
- Sponsor/Initiator Radboud University Medical Center Nijmegen
- Funding
(Source(s) of Monetary or Material Support)
None
- Publications
- Brief summary
- Main changes (audit trail)
- RECORD11-jun-2015 - 22-nov-2015


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl