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NCT02428062: THE BRIDGE
Effect of Target Intraoperative Blood Pressure on the Incidence of Post-operative Cognitive Dysfunction in Patients Aged 75 and Older Undergoing General Anesthesia for Non-cardiac Surgery: an International Multicenter Randomized Controlled Trial
Phase 2/Phase 3 trial testing Hemodynamic target in Post-operative Cognitive Dysfunction in 1,812 participants. Suspended.
1 December 2018
Quick facts
| Lead sponsor | Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico |
|---|---|
| Phase | Phase 2/Phase 3 |
| Status | Suspended |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | prevention |
| Enrollment | 1,812 |
| Start date | 1 October 2014 |
| Primary completion | 1 December 2018 |
| Estimated completion | 1 December 2019 |
| Sites | 1 location across Italy |
Drugs / interventions tested
- Hemodynamic target
- Phenylephrine (phenylephrine) — full drug profile →
- Intravenous fluids
- Patient's positioning
- Reduction of depth of anesthesia
- Ephedrine (EPHEDRINE) — full drug profile →
- Epinephrine (epinephrine) — full drug profile →
- Norepinephrine (NOREPINEPHRINE) — full drug profile →
- Dopamine (DOPAMINE) — full drug profile →
Conditions studied
- Post-operative Cognitive Dysfunction — all drugs for Post-operative Cognitive Dysfunction →
Sponsor
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Who can join
75 and older, any sex, with Post-operative Cognitive Dysfunction. Healthy volunteers can join.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Post-operative cognitive dysfunction (POCD) at 3 months
Time frame: 3 months after surgical operation
For each of the neuropsychological tests a Z-score will be calculated. The Z score represents the magnitude of the deviation (in number of standard deviations) in the test results from the reference (Control Group). The Z-score is calculated as the difference between the baseline and the 3 months test result for a patient, corrected for the expected difference (the mean difference for that test o
Sponsor's own description
BACKGROUND: Post-operative cognitive dysfunction (POCD) is a potentially irreversible loss of brain functions observed in elderly patients after surgical operations under general anaesthesia. POCD at 3 post-operative months is observed in up to 15% of patients aged 70 years and more, and the only recognized risk factor for this condition is increasing age. Importantly, the incidence of POCD at 3 months has been associated to an increased disability and mortality. OBJECTIVES: The present study will evaluate in patients aged 75 years and older undergoing general anaesthesia for non-cardiac surgery, whether an hemodynamic strategy, aiming at maintaining intra-operative arterial blood pressure close to patient's preoperative blood pressure, i.e., to avoid hypotensive episodes, reduces the incidence of POCD at three months. METHODS: Around 1800 consecutive patients scheduled to undergo general anaesthesia for elective non-cardiac surgery will be enrolled. Each patient's cognitive function will be evaluated preoperatively and at 3 months and 1 year postoperatively, together with the occurrence of hearing loss and vestibular function impairment. Furthermore, the incidence of postoperative delirium and cardiovascular, respiratory and infectious complications will be evaluated. EXPECTED RESULTS: The primary outcome is a 25% relative reduction in the incidence of POCD at 3 postoperative months. Secondary outcomes are the reduction of POCD incidence at 1 postoperative year, a reduction in postoperative hearing loss and vestibular impairment at 3 months, a reduction in the incidence of delirium. Hospital length of stay and 90 day mortality will also be assessed. This present study could have a high socio-economic impact, reduce healthcare costs and patient morbidity and mortality with a simple not expensive intraoperative intervention.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT02428062
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT02428062 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
- Last refreshed: 12 April 2018
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02428062.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing