No registrations found.
ID
Source
Brief title
Health condition
Post-operative infection
Surgical site infection
Pneumonia
Sepsis
Sponsors and support
Intervention
Outcome measures
Primary outcome
Main study outcome is the assessment of immune cell function after BCG vaccination and after surgery
Secondary outcome
Secondary outcomes are the occurrence of SSI, pneumonia, sepsis, UTI, ileus
Background summary
Despite strictly implemented perioperative infection-preventive strategies, postoperative infection rates are still high (up to 20%). Surgery- and anesthesia induced immunosuppression contributes to such infections, which are associated with high mortality rates. In this project, this perioperative-induced immunosuppression will be investigated by a unique approach: We aim to improve patient’s host defence mechanisms by vaccination with Bacillus Calmette–Guérin (BCG), in order to facilitate a more efficient elimination of pathogens during the perioperative period. The inflammatory response after elective laparotomic surgery in BCG-vaccinated patients will be compared with placebo–vaccinated patients in a double-blind randomized trial.
Study objective
We hypothesize that induction of trained immunity through BCG vaccination may improve host defence mechanisms of patients throughout the perioperative period.
Study design
- Immediately before the intervention
- Immediately pre-surgery (before induction of anesthesia)
- Immediately post-surgery (on the arrival at the recovery room)
- 30 days after surgery (between 28-32 days)
- 90 days after surgery (between 80-100 days)
Intervention
BCG vaccination
Geert Grooteplein Zuid 10
Nijmegen 6525 GA
The Netherlands
+31 24 3668289
Leonie.Helder@radboudumc.nl
Geert Grooteplein Zuid 10
Nijmegen 6525 GA
The Netherlands
+31 24 3668289
Leonie.Helder@radboudumc.nl
Inclusion criteria
Willing and able to provide written informed consent.
No acute infection at the time of vaccination or surgery (defined as fever above 38.5 ¢XC).
Patients scheduled for:
Colon surgery, sigmoid surgery, or rectal surgery via an open laparotomy.
Liver and gall bladder surgery via an open laparotomy.
Pancreas surgery (Whipple procedures) via an open laparotomy.
Uterus/ovaria extirpations, tumour debulking surgery via an open laparotomy.
Nefrectomy/urinary bladder surgery via an open laparotomy.
Vascular surgery (aortic) via an open laparotomy.
Exclusion criteria
Immunosuppressed status, due to medication or otherwise.
Corticosteroid or other immunosuppressive treatment, including general radiation. Inhaled steroids are not a contra-indication.
Malignant condition such as lymphoma, leukaemia or other tumour of the reticulo-endothelial system that is not in remission.
HIV infection
Auto-inflammatory or auto-immune 㻠diseases.
Pregnancy or lactation.
Any serious or active medical or psychiatric illness which would interfere with treatment, assessment, or compliance.
History of TBC infection or positive Mantoux test, contact with TBC patients or born in a TBC endemic country.
Vaccination within 3 months prior to inclusion (subjects cannot be vaccinated with other vaccines during the study).
Previous BCG vaccination or known allergy or hypersensitivity to BCG vaccine.
History of serious atherosclerotic disease (unstable Angina Pectoris, history of ischemic CVA).
History of diabetes mellitus type 2 with metformin as anti-diabetic medication.
Participation in a clinical study with an investigational drug or biologic within 28 days prior to screening visit.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL7092 |
| NTR-old | NTR7290 |
| CCMO | NL66332.091.18 |