ISRCTN - ISRCTN53154834: Balanced crystalloids versus balanced colloids within a goal-directed haemodynamic protocol in patients undergoing gynaecological tumour resection

Plain English Summary

Lay summary under review 3

Trial website

Contact information

Type

Scientific

Primary contact

Prof Claudia Spies

ORCID ID

Contact details

Augustenburger Platz 1
Berlin
13353
Germany

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

EK 12 581/08

Study information

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

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.

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

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Phase IV

Drug names

Primary outcome measures

Differences of intra-operatively administered amount of intravenous fluids (balanced colloid versus balanced crystalloid solutions) within a goal-directed haemodynamic management

Secondary outcome measures

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.

Overall trial start date

01/05/2009

Overall trial end date

30/06/2011

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

50

Participant 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

Recruitment start date

01/05/2009

Recruitment end date

30/06/2011

Locations

Countries of recruitment

Germany

Trial participating centre