Balanced crystalloids versus balanced colloids within a goal-directed haemodynamic protocol in patients undergoing gynaecological tumour resectio

Phase 4

Completed

• Conditions: Gynaecological tumour resection; Surgery; Tumour resection

• Registration Number: ISRCTN53154834
• Lead Sponsor: Charité - University Medicine Berlin (Charité - Universitätsmedizin Berlin) (Germany)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-08-27
• Last Update Posted: 9 October 2017

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 50

Inclusion Criteria

1. Female patients aged 18 and over
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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified