Comparison of Two Gelatine Solutions
Paraules clau
Resum
Dates
| Darrera verificació: | 10/31/2013 |
| Primer enviat: | 01/01/2012 |
| Inscripció estimada enviada: | 01/17/2012 |
| Publicat per primera vegada: | 01/23/2012 |
| Última actualització enviada: | 11/25/2013 |
| Publicació de l'última actualització: | 11/26/2013 |
| Data d'inici de l'estudi real: | 11/30/2011 |
| Data estimada de finalització primària: | 12/31/2012 |
| Data estimada de finalització de l’estudi: | 12/31/2012 |
Condició o malaltia
Intervenció / tractament
Drug: balanced gelatine solution
Drug: non-balanced gelatine solution
Fase
Grups de braços
| Braç | Intervenció / tractament |
|---|---|
| Experimental: balanced gelatine solution isotonic colloidal volume substitute | Drug: balanced gelatine solution Gelofusine balanced combined with Sterofundin ISO |
| Active Comparator: non-balanced gelatine solution colloidal volume substitute | Drug: non-balanced gelatine solution Gelofusine 4% combined with NaCl 0.9% |
Criteris d'elegibilitat
| Edats elegibles per estudiar | 18 Years Per a 18 Years |
| Sexes elegibles per estudiar | All |
| Accepta voluntaris saludables | Sí |
| Criteris | Inclusion: - Male or female patients >= 18 years of age and <= 90 years of age. Women of child bearing potential must test negative on standard pregnancy test. - Patients scheduled to undergo elective abdominal surgery (e.g. Rectal resection, liver resection, open bowl resection, duodenopancreatectomy reconstitution). - Scheduled intraoperative volume requirement of at least 15 ml / kg body weight (BROCA) gelatine solution - Provision of voluntary consent to participate in the study, following a full explanation of the nature and purpose of the study, by signing the informed consent form approved by the Institutional Ethics Committee (IEC) prior to all evaluations. Exclusion: - Patients of ASA-class > III - Known hypersensitivity to gelatine or to any of the constituents of the solution - Patients treated with other colloid solutions and / or blood products 24 hours prior to surgery - Patients on hemodialysis - Patients suffering from decompensated renal function (i.e. serum creatinine > 3.0 mg/dl) - Patients suffering from Hypervolemia Hyperhydration Severe blood coagulation disorders Hypernatremia (serum(Na+) > 150 mmol/L) Hyperchloremia (serum(Cl-) > 110 mmol/L) - Estimated perioperative need for blood products of 3,5 ml / kg body weight (BROCA) - Lactation period - Simultaneous participation in another clinical trial - Emergencies |
Resultat
Mesures de resultats primaris
1. base excess [mmol/l] [Change from baseline at end of surgery, an expected average of 2 hours surgery]
2. chloride [mmol/l] [Change from baseline at end of surgery, an expected average of 2 hours surgery]
Mesures de resultats secundaris
1. arterial blood gase analyses [until 12 hours after surgery]
2. coagulation status [until 12 hours after surgery]
3. renal function [until 12 hours after surgery]
4. adverse events [until 12 hours after surgery]
5. hemodynamics (systolic and diastolic blood pressure) [until 12 hours after surgery]
6. time on ventilation [until 12 hours after surgery]
