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| [ ...Back to search results ] | [ Print-friendly version ] |
| Balanced crystalloids versus balanced colloids within a goal-directed haemodynamic protocol in patients undergoing gynaecological tumour resection |
| ISRCTN | ISRCTN53154834 |
| ClinicalTrials.gov identifier | |
| Public title | Balanced crystalloids versus balanced colloids within a goal-directed haemodynamic protocol in patients undergoing gynaecological tumour resection |
| Scientific title | Balanced crystalloids versus balanced colloids within a goal-directed haemodynamic protocol in patients undergoing gynaecological tumour resection: a prospective, randomised, controlled, double-blinded, two-armed single centre trial |
| Acronym | BalaCriCo |
| Serial number at source | EK 12 581/08 |
| Study hypothesis |
A balanced colloid solution is superior to a balanced crystalloid solution for volume replacement in regard of lower amounts of intra-operatively administered intravenous solutions.
As of 03/11/2010 this record has been updated to include an extended anticipated end date; the initial anticipated end date of this trial was 30/10/2010. |
| Lay summary | |
| Ethics approval | Ethics Committee of the Landesamt für Gesundheit und Soziales Berlin (LaGeSo), Germany, approved on the 19th December 2008 (ref: EK 12 581/08) |
| Study design |
Prospective randomised controlled double-blinded two-armed single centre phase IV trial
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| Countries of recruitment | Germany |
| Disease/condition/study domain | Gynaecological tumour resection |
| Participants - inclusion criteria |
1. Female patients aged greater than or equal to 18 years
2. Patients with metastatic ovarian carcinoma undergoing a tumour reduction operation at the University Hospital, Campus Virchow-Klinikum of the Charité - University Medicine Berlin 3. Offered patient information and written informed consent 4. No participation in another clinical trial during the trial until the 10th post-operative day |
| Participants - exclusion criteria |
1. Aged less than 18 years
2. Pregnancy or lactation 3. Lacking willingness to save and hand out pseudonymised data within the clinical study 4. Accommodation in an institution due to an official or judicial order 5. Advanced disease of the oesophagus of nasopharyngeal cavity 6. Operations in the area of the oesophagus or nasopharynx within the last two months 7. Liver disease (Child B or C cirrhosis, end-stage liver disease [MELD] score greater than 10) 8. Conditions after acute or chronic pancreatitis 9. History of bleeding tendency, e.g. Von Willebrands disease 10. Neurological or psychiatric disease 11. Unclear history of alcohol related disorder 12. Chronic heart failure class IV according to the New York Heart Association (NYHA) 13. American Society of Anaesthesiologists (ASA) classification greater than III 14. Renal insufficiency (serum creatinine greater than 2.0 mg/dl or greater than 150 µmol/l or dependency of haemodialysis) 15. Existence of a pulmonary oedema in the pre-operative chest x-ray 16. Allergy to hydroxyethyl starch or other ingredients of the intravenous solutions 17. History of intracranial haemorrhage within one year before participation in the study 18. Hyperkalaemia greater than 5.8 mmol/l and hypernatriaemia greater than 155 mmol/l 19. Pre-operative ileus symptomatology 20. Known history of hypermagnesaemia 21. Known history of metabolic alkalosis 22. Derailed diabetes mellitus (glucose greater than 300 mg/dl) before inclusion |
| Anticipated start date | 01/05/2009 |
| Anticipated end date | 30/06/2011 |
| Status of trial | Completed |
| Patient information material | Not available in web format, please use the contact details below to request a patient information sheet |
| Target number of participants | 50 |
| Interventions |
During gynaecological tumour resection:
1. Intra-operative oesophageal Doppler guided fluid management with a balanced colloid solution 2. Intra-operative oesophageal Doppler guided fluid management with a balanced cristalloid solution The dosage will be guided by the stroke volume and the corrected flow time of the heart measured by the oesophageal Doppler. The duration of the study protocol identical to the administration of the study medication is from the beginning of the operation up to the end of the operation. Total intravenous Dose per day is 50 ml/kg BW/d for Volulyte and 50 ml/kg BW per day for Jonosteril. Follow up will be 3 months after drug application for all arms. |
| Primary outcome measure(s) | Differences of intra-operatively administered amount of intravenous fluids (balanced colloid versus balanced crystalloid solutions) within a goal-directed haemodynamic management |
| Secondary outcome measure(s) |
1. Doses and duration of therapy with catecholamines measured intra-operatively and post-operatively during intensive care unit (ICU) stay
2. Time and number of hypotensive episodes measured intra-operatively and post-operatively during ICU stay 3. The quantity of intravenous fluid admininstered to the patient during the first 18 hours after surgery 4. The quantity of fluids per day lost by drainage during the first three days after surgery 5. Time that discharge criteria were met (measured by Post-Anaesthetic Discharge Scoring System [PADSS]) 6. Length of intensive care stay and length of hospital stay (LOS) 7. The rate of post-operative organ dysfuntions and complications (cardiac, pulmonal, renal, gastrointestinal) 8. The rate of post-operative delirium and the post-operative incidence of post-operative, cognitive dysfunction 9. Weight change until the fifth post-operative day 10. Peri-operative incidence of infections (according to the Centers for Disease Control and Prevention [CDC] and American Thoracic Society [ATS] criteria) 11. Patient, surgeon and anaesthetic satisfaction 12. Pain of the patient 13. Quality of life measure before the operation, at the day of hospital discharge and three months after surgery 14. Laboratory tests: peri-operative endothelial and immunological alterations The secondary outcome measures were determined if above not specified within the study up to the 10th post-operative day. |
| Sources of funding | Charité - University Medicine Berlin (Charité - Universitätsmedizin Berlin) (Germany) |
| Trial website | |
| Publications | |
| Contact name | Prof Claudia Spies |
| Address | Augustenburger Platz 1 |
| City/town | Berlin |
| Zip/Postcode | 13353 |
| Country | Germany |
| Sponsor | Charité - University Medicine Berlin (Charité - Universitätsmedizin Berlin) (Germany) |
| Address | Charitéplatz 1 |
| City/town | Berlin |
| Zip/Postcode | 10117 |
| Country | Germany |
| c.krukenkamp@charite.de | |
| Sponsor website: | http://www.charite.de/ |
| Date applied | 14/07/2009 |
| Last edited | 03/11/2010 |
| Date ISRCTN assigned | 27/08/2009 |
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