Effect of liquid with starch (Voluven) versus liquid without starch (Lactated Ringer) in elective abdominal operation.

Conditions: eoplasma malignum vesicae urinariae
MedDRA version: 14.0Level: LLTClassification code 10005004Term: Bladder cancer NOSSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2011-003270-80-DK

Lead Sponsor: Kirsten Rasmussen

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 40

Inclusion Criteria

Patienter over 18 år med indikation for elektiv postrenal aflastende operation med cystektomi.
Hvis patienten er i antikoagulationsbehandling skal der være holdt pause med AK-behandling, ASA- og NSAID præparater i 5 dage.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

Patienter med intrakraniel blødning, dialysekrævende nyresvigt, manifest hjerteinsufficiens, svær leversygdom og/eller svære koagulationsforstyrrelser (anamnestisk oplyst).
Gravide og ammende (negativ graviditetstest ved inklusionen)
Allergi overfor hydroxyethylstivelser
Svær hypernatriæmi og hyperkloræmi.
Patienter under værgetilsyn.
Patienter, der indgår i et andet forsøg, såfremt det interfererer med nærværende forsøg

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To investigate if coagulation and loss of blood during the operation depends on the type of liquid usen to keep the patient normovolaemic estimated by optimizing cardiac output.;Secondary Objective: ;Primary end point(s): To estimate coagulation during operation when the patient is normovolaemic;Timepoint(s) of evaluation of this end point: After infusion, end of operation and two hours later

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): estimate the amount of blood loss and need for transfusion;Timepoint(s) of evaluation of this end point: end of operation and two houra later