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

ISRCTN	ISRCTN53154834
DOI	https://doi.org/10.1186/ISRCTN53154834
Protocol serial number	EK 12 581/08
Sponsor	Charité - University Medicine Berlin (Charité - Universitätsmedizin Berlin) (Germany)
Funder	Charité Universitätsmedizin Berlin

Submission date: 14/07/2009
Registration date: 27/08/2009
Last edited: 22/09/2017

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Surgery

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Background and study aims
This study will recruit 50 women with metastatic ovarian carcinoma (ovarian cancer that has spread) undergoing a tumour reduction operation. Colloid and crystalloid solutions are given into a patient’s vein (intravenously) during surgery to maintain blood volume. The aim of this study is to find out whether a colloid solution is better than a crystalloid solution for volume replacement (i.e. a lower amount of solution is needed).

Who can participate?
Women aged 18 or over with metastatic ovarian carcinoma undergoing a tumour reduction operation at the University Hospital, Campus Virchow-Klinikum of the Charité - University Medicine Berlin

What does the study involve?
Participants are randomly allocated to receive either a colloid or crystalloid solution intravenously during their surgery. The amount of fluid used is measured, along with other factors such as length of intensive care and hospital stay, complications, pain and quality of life.

What are the possible benefits and risks of participating?
There are no additional treatments or tests for the participants, and the study drugs are common medicines used in everyday hospital routine. The risk to participants is low and there is a low risk of side effects to the study drugs.

Where is the study run from?
Charité - University Medicine Berlin (Germany)

When is the study starting and how long is it expected to run for?
May 2009 to June 2011

Who is funding the study?
Charité - University Medicine Berlin (Germany)

Who is the main contact?
Prof. Claudia Spies

Contact information

Prof Claudia Spies
Scientific

Augustenburger Platz 1
Berlin
13353
Germany

Study information

Primary study design	Interventional
Study design	Prospective randomised controlled double-blinded two-armed single-centre phase IV trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
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
Study acronym	BalaCriCo
Study objectives	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.
Ethics approval(s)	Ethics Committee of the Landesamt für Gesundheit und Soziales Berlin (LaGeSo), Germany, 19/12/2008, ref: EK 12 581/08
Health condition(s) or problem(s) studied	Gynaecological tumour resection
Intervention	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.
Intervention type	Procedure/Surgery
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
Key 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 measured 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.
Completion date	30/06/2011

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Female
Target sample size at registration	50
Key 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
Key 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
Date of first enrolment	01/05/2009
Date of final enrolment	30/06/2011

Locations

Countries of recruitment

Germany

Study participating centre

Charité - University Medicine Berlin (Charité - Universitätsmedizin Berlin)

Berlin
13353
Germany

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/02/2013		Yes	No
Results article	substudy results	01/07/2017		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

22/09/2017: Plain English summary added.
17/07/2017: Publication reference added.
03/11/2010: The overall trial end date was changed from 30/10/2010 to 30/06/2011.