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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03152734
Other study ID # 17-070
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 1, 2017
Est. completion date January 30, 2019

Study information

Verified date November 2019
Source RWTH Aachen University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The POSE study will predict critical stages and outcome in a large sample of all surgical and non-surgical interventional patients ≥80 years of age in Europe.


Description:

Elderly population (≥80 years) will increase from 5.3% of the total population in 2015 to 9% in 2040. This implies an increasing number and variety of surgical and non-surgical interventional procedures. Little is known about the in-hospital mortality rates in the overall elderly interventional population. Compared with younger interventional patients, the elderly are at greater risk of peri-interventional mortality and morbidity, because of decline in physiological and cognitive reserve, and frequent comorbidities. Previous data are mostly limited to specific populations, like the elderly hip fracture patient.

The investigators aim to recruit as many as possible centers throughout Europe, to participate in this study. A total sample size of 7500 patients will provide reasonable and valid results for the study aims. The primary endpoint will be analysed by fitting a COX-Regression model to the data of the post-interventional mortality until day 30.


Recruitment information / eligibility

Status Completed
Enrollment 9500
Est. completion date January 30, 2019
Est. primary completion date January 30, 2019
Accepts healthy volunteers No
Gender All
Age group 80 Years and older
Eligibility Inclusion Criteria:

- Age = 80 years

- Written informed consent according to the national law requirements

- All consecutive patients undergoing surgical and non-surgical interventions (e.g. radiological, neuroradiological, cardiological, gastroenterological) with anaesthesia care (done by an anaesthetist) within the selected inclusion period of four weeks

- Elective and emergency procedures

- In-patient and out-patient procedures

Exclusion Criteria:

- People who are institutionalized by court or administrative order

- Patients with re-intervention within the 4 week period, who were already enrolled in this study

Study Design


Intervention

Procedure:
Surgical or non-surgical intervention
Each kind of surgical or non-surgical intervention with anesthesia applied by an anesthetist

Locations

Country Name City State
Austria University Hospital Salzburg Salzburg
Belgium ZNA Middelheim Antwerpen
Belgium Universitair Ziekenhuis Antwerpen Edegem
Belgium Ziekenhuis Oost-Limburg Genk
Belgium Ghent University Hospital Gent
Belgium AZ Groeninge Kortrijk
Belgium University Hospital Leuven Leuven
Belgium AZ Turnhout Turnhout
Denmark Aarhus Universityhospital Aarhus
Denmark Rigshospitalet Copenhagen
Denmark Rigshospitalet, Neuroscience Centre Copenhagen
Denmark Herlev Hospital Herlev
Denmark Nordsjællands Hospital Hillerød
Denmark Hospital Unit Horsens Horsens
Denmark Hospitaln Lillebælt Vejle
France CHU Amiens Picardie Amiens
France CHU Angers Angers
France Centre Hospitalier Fleyriat Bourg-en-Bresse
France Centre hospitalier Pierre Oudot Bourgoin-Jallieu
France HIA Clermont Tonnerre Brest
France Hopital d'Instruction des Armées Percy Clamart
France CH Le Mans Le Mans
France Huriez Hospital, University Hospital of Lille Lille
France Clinique de la Sauvegarde Lyon
France Croix Rousse Hospital Lyon
France Hopital Edouard Herriot Lyon
France Hôpital Lyon Sud Lyon
France Neurologic Hospital-Hospices Civils de Lyon Lyon
France AP-HM Hôpital Nord Marseille
France CH Martigues Martigues
France Clinique Saint Jean Montpellier
France Centre Hospitalier Universitaire de Nantes Nantes
France CHU Nantes Nantes
France AP-HP, Hopital Saint-Louis Paris
France Cochin University Hospital Paris
France Hopital de la Pitié-Salpe tri ere Paris
France Hopital Saint Antoine Paris
France Centre Hospitalier Universitaire de Poitiers Poitiers
France Hopital Prive Claude Galien Quincy-sous-Sénart
France University Hospital of Reims Reims
France CHU Hôpital Nord Saint-Étienne
France Clinique Mutualiste Saint Etienne Saint-Étienne
France Polyclinique de l'atlantique Saint-Herblain
France Groupe Hospitalier Selestat-Obernai Sélestat
France Clinique Trenel St Coulomb
France Hopital Foch Suresnes
France Centre Hospitalier de Bigorre Tarbes
France CHU Toulouse Toulouse
France Gustave Roussy Cancer Center Villejuif
Georgia Health centre "Medina" Batumi
Georgia 5th General Hospital "Open Heart" Tbilisi
Georgia Acad. N. Kipshidze Central University Clinic Tbilisi
Georgia EVEX Traumatology Hospital Tbilisi
Georgia Medical Corporation Evex, Tbilisi Referral Hospital Tbilisi
Georgia Mediclubgeorgia Tbilisi
Georgia New Hospital Tbilisi
Georgia Oftalmij Tbilisi
Georgia Medical Corporation Evex - Zugdidi Referral Hospital Zugdidi
Germany Department of Anesthesiology, University Hospital Aachen Aachen NRW
Germany St. Josef- Hospital Bochum
Germany University Hospital Knappschaftskrankenhaus Bochum Bochum
Germany University of Bonn Bonn
Germany University Hospital Carl Gustav Carus Dresden Dresden
Germany Heinrich-Heine University Duesseldorf Duesseldorf
Germany University Hospital Frankfurt Frankfurt
Germany Hannover Medical School Hannover
Germany Marien Hospital Herne, UK der Ruhr-Universität Bochum Herne
Germany Jena University Hospital Jena
Germany Universitätsklinikum Schleswig-Holstein Campus Luebeck Luebeck
Germany Universitaetsklinikum Marburg Marburg
Germany Johannes Wesling Klinikum Minden Minden
Germany Klinikum der Ludwigs-Maximilians-Universität München (LMU) Muenchen
Germany Klinikum rechts der Isar der TU München Muenchen
Germany St. Franziskus-Hospital Münster Münster
Germany University Hospital Münster Münster
Germany Klinikum Oldenburg AÖR Oldenburg
Germany University Hospital Tübingen Tuebingen
Germany Kliniverbund St. Antonius und St. Josef GmbH Wuppertal
Germany University Hospital of Wuerzburg Würzburg
Greece Democritus University of Thrace Alexandroupolis
Greece Alexandra Hospital Athens
Greece Evangelismos General Hospital Athens
Greece General Hospital of Athens "G. Gennimatas" Athens
Greece Onassis Cardiac Surgery Center Athens
Greece Attikon University Hospital Chaïdári
Greece University Hospital of Ioannina Ioánnina
Greece General Hospital of Kavala Kavála
Greece Komotini General Hospital Komotiní
Greece University Hospital of Larissa Larissa
Greece University Hospital of Patras Patra
Greece Tzaneio General Hospital of Pireaus Piraeus
Greece AHEPA University Hospital Thessaloníki
Greece General Hospital Papanikolaou Thessaloníki
Greece George Papanikolaou Thessaloníki
Greece Hippokrateion General Hospital Thessaloníki
Greece Medical School, Aristotle University of Thessaloniki Thessaloníki
Greece Theagenio Cancer Hospital Thessaloníki
Greece General Hospital of Veroia Véroia
Greece General Hospital of Volos "Achillopouleio" Volos
Ireland Cork University Hospital Group Cork
Ireland St Vincents University Hospital Dublin
Ireland Tallaght Hospital Dublin
Israel Shaare Zedek Medical Center Jerusalem
Israel Galilee Medical Center Nahariya
Israel Rabin Medical Center Beilinson Hospital Petah tikva
Israel Sheba Academic Medical Center Ramat Gan
Israel Tel Aviv Sourasky Medical Center Tel Aviv
Netherlands Albert Schweitzer Hospital Dordrecht
Netherlands Maastricht UMC+ Maastricht
Netherlands Maasstad Ziekenhuis Rotterdam
Netherlands University Medical Center Utrecht Utrecht
North Macedonia University Clinic for Gyn & Ob / Clinical Center Mother Teresa Skopje
North Macedonia University Clinic for Traumatology, Orthopedics, Anesthesia, Reanimation, and Intensive Care Medicine Skopje
Poland Jagiellonian University Medical College Kraków
Portugal Centro Hospitalar e Universitario de Coimbra Coimbra
Portugal Centro Hospitalar Lisboa Norte - Hospital Santa Maria Lisboa
Portugal Centro Hospitalar Tamega e Sousa Penafiel
Romania Clinical Emergency Hospital of Bucharest Bucharest
Romania Fundeni Clinical Institute Bucharest
Romania University Emergency Central Military Hospital Bucharest
Romania Emergency Institute for Cardiovascular Diseases "Prof CC Iliescu" Bucuresti
Romania Emergency County Hospital Cluj Cluj-Napoca
Russian Federation GBUZ Chelyabinsk Regional Clinical Center of Oncology and Nuclear Medicine Chelyabinsk
Russian Federation Federal State Autonomous Institution N.N. Burdenko National medical research center of neurosurgery of the ministry of health of the Russian federation (N.N. Burdenko NMRCN) Moscow
Russian Federation NN Blokhin National Medical Cancer Research Center Moscow
Russian Federation P.A. Herzen Moscow Cancer Research Institute Moscow
Serbia Cardiovacular Institute Dedinje Belgrade
Serbia CHC Bezaniska Kosa Belgrade
Serbia Clinic for ENT and maxillofacial surgery, Clinical Center of Serbia Belgrade
Serbia Clinic for orthopedics surgery and traumatology Clinical center of Serbia Belgrade
Serbia Clinical Center of Serbia, Cener for anaestesia , Department for digestive surgery Belgrade
Serbia Clinical Centre of Serbia Belgrade
Serbia Emergency Center, Clinical Center of Serbia Belgrade
Serbia Urology Hospital, Clinical center of Serbia Belgrade
Serbia Clinical Center Nis Niš
Serbia General Hospital Sremska Mitrovica Sremska Mitrovica
Spain Hospital Universitario Fundacion Alcorcon Alcorcón
Spain Consorci Sanitari Integral Barcelona
Spain CSI Hospital General de l'Hospitalet Barcelona
Spain Hospital de la Santa Creu i Sant Pau Barcelona
Spain Hospital Universitari Sagrat Cor Barcelona
Spain Universitary General Hospital of Ciudad Real Ciudad Real
Spain Hospital Universitario de Gran Canaria Doctor Negrin Las Palmas De Gran Canaria
Spain Hospital of Leon León
Spain San Pedro Hospital Logroño
Spain Hospital General Gregorio Maranon Madrid
Spain Hospital Ramon y Cajal Madrid
Spain Hospital Universitario Infanta Leonor Madrid
Spain Hospital Universitario La Princesa Madrid
Spain Hospital de Sant Joan Despí Moises Broggi - Consorci Sanitari Integral Sant Joan Despí
Spain Hospital Clinico Universitario Valencia
Spain Hospital Universitario Araba Vitoria
Spain Hospital Universitario Miguel Servet Zaragoza
Switzerland University Hospital Basel Basel
Switzerland Kantonsspital Baselland Liestal Liestal
Switzerland Hirslanden Clinic St. Anna Lucern Lucerne
Switzerland Spital Limmattal Schlieren
Switzerland Bürgerspital Solothurn Solothurn
Turkey Ankara University Cebeci Hospital Ankara
Turkey Ankara University Faculty of Medicine-Ibni Sina Hospital Ankara
Turkey Ufuk University Dr. Ridvan Ege Hospital Ankara
Turkey University of Health Sciences Diskapi Yildirim Beyazit Education and Training Hospital Ankara
Turkey Balikesir Atatürk City Hospital Balikesir
Turkey Kocaeli Derince Training and Research Hospital Derince
Turkey TR Ministry of Health Erzurum Palandoken State Hospital Erzurum
Turkey Baltalimani Metin Sabanci Bone and Joint Diseases Education and Research Hospital Istanbul
Turkey Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital Istanbul
Turkey Istanbul University, Istanbul Faculty of Medicine Istanbul
Turkey Marmara University Pendik Training and Research Hospital Istanbul
Turkey Dokuz Eylul University Faculty of Medicine Izmir
Turkey Saglik Bilimleri University Tepecik Education and Research Hospital Izmir
Turkey Baskent University Konya Research Center Konya
Turkey Konya Education and Research Hospital Konya
Turkey RTE university school of medicine Rize
Turkey Sakarya University School od Medicine Sakarya
Turkey Republic of Turkey Ministry of Health Tunceli State Hospital Tunceli
Ukraine Zaporizhzhia State Medical University Zaporizhzhya

Sponsors (1)

Lead Sponsor Collaborator
Mark Coburn

Countries where clinical trial is conducted

Austria,  Belgium,  Denmark,  France,  Georgia,  Germany,  Greece,  Ireland,  Israel,  Netherlands,  North Macedonia,  Poland,  Portugal,  Romania,  Russian Federation,  Serbia,  Spain,  Switzerland,  Turkey,  Ukraine, 

Outcome

Type Measure Description Time frame Safety issue
Other Age and gender-effect on the 30 day mortality Association of patient age/ gender and mortality 30 days after intervention
Other Effect of pre-interventional morbidities on the 30 day mortality Association of pre-operative morbidities and mortality 30 days after intervention
Other Effect of type of surgery or non-surgical intervention on the 30 day mortality Association of type of surgery or non-surgical intervention and mortality 30 days after intervention
Other Effect of centre and country on the 30 day mortality Association of center/ country and mortality 30 days after intervention
Other In-hospital cardiopulmonary resuscitation Rate From intervention until hospital discharge or maximum 30-days after intervention
Primary Peri-interventional (surgical and non-surgical interventional) all-cause mortality rate on day 30 Number of patients with death from any cause From intervention until day 30.
Secondary In-hospital outcome according to the ACS National Surgical Quality Improvement Program® (ACS NSQIP®) Number of patients with e.g. pneumonia, cardiovascular complication, surgical site infection, urinary tract infection, venous thromboembolism, acute or progressive renal failure and re-surgery From intervention until day 30.
Secondary Analysis of the new-onset of serious cardiac complications Number of patients with serious cardiac complication
Cardiac complication is defined according to the American Heart Association
From intervention up to 30-days after intervention
Secondary Analysis of the new-onset of serious pulmonary complications Number of patients with
Pneumonia: Clinical or radiological diagnosis. or
Pulmonary embolism: Radiological diagnosis. Signs of pneumonia or pulmonary embolism in the autopsy
From intervention up to 30-days after intervention
Secondary Analysis of the new-onset of acute stroke Number of patients with new-onset of acute stroke, defined as a new focal or generalised neurological deficit of >24h duration in motor, sensory, or coordination functions with compatible brain imaging and confirmed by a neurologist. Transient ischemic attack is not considered as acute stroke. Signs of stroke in the autopsy. From intervention up to 30-days after intervention
Secondary Analysis of the new-onset of acute kidney injury Number of patients with new-onset of acute kidney injury, defined according to the AKIN classification as AKI stage =2.
This means increase of creatinine >2-3x from baseline within the hospital stay. Or urine output less than 0.5 ml kg-1 per hour for more than 12 hours. Or signs of acute kidney injury in the autopsy.
From intervention up to 30-days after intervention
Secondary Unplanned intensive care unit admission Number of patients From intervention until hospital discharge or maximum 30-days after intervention
Secondary Unplanned intubation after intervention Number of patients From intervention until hospital discharge or maximum 30-days after intervention
Secondary Hospital discharge destination Number of patients, who are not discharged, discharged home, discharged to rehabilitation, discharged to other hospital, discharged to a nursing home, diseased in hospital or discharged to another destination, respectively. From intervention until hospital discharge or maximum 30-days after intervention
Secondary Perioperative admission to a unit with a geriatric care model Number of patients, which are post-interventionally admitted to e.g. geriatric units, geriatric co-management models, geriatric liaison services From intervention until hospital discharge or maximum 30-days after intervention
Secondary Patient`s functional status of independency Scale assessed by interview of the patient according to the NSQIP (Independent, partially dependent, totally dependent). On day 30 after intervention
Secondary Brief screen for cognitive impairment Number of correct recall of three words (Brief Screen for Cognitive Impairment test) On day 30 after intervention
Secondary Comparing the postoperative in-hospital and 30-day outcome with preoperatively via NSQIP risk calculator and POSPOM predicted outcome for surgeries Comparing the number of via preoperative NSQIP risk calculator and POSPOM predicted outcomes with the number of postoperative outcomes of the patient On day 30 after intervention
Secondary Number of used intra-interventional monitoring for elderly patients in the clinical routine Number of patients, where a specific monitoring device was intra-interventionally used Intra-interventional
Secondary Number of patients with premedication Number of patients with premedication given before intervention. Intra-interventional
Secondary Type of anesthesia technique Number of patients with a specific type of anesthesia technique (e.g. spinal, general etc) Intra-interventional
Secondary Type of the main anesthetic Number of patients with a specific type of anesthesia drugs (e.g. desflurane, isoflurane etc.) Intra-interventional
Secondary Type of the main intra-interventional opioid Number of patients with a specific type of opioid for anesthesia (e.g. fentanyl etc.) Intra-interventional
Secondary Anesthesia duration Begin to end of anesthesia for intervention Intra-interventional
Secondary Amount of intra-interventionally transfused blood and blood products e.g. transfusion of packed red blood cells, fresh frozen plasmas and platelets Intra-interventional
Secondary Number of extubated patients At the end of intervention Intra-interventional
Secondary Kind of intervention Surgical procedure category, severity, urgency, wound class Intra-interventional
Secondary Use of WHO safe surgery checklist Number of patients , where the WHO safe surgery checklist was used Intra-interventional
Secondary Kind of referring facility Number of patients referred from home,other hospital, rehabilitation, nursing home or other referring facility, respectively. Pre-interventional at baseline visit
Secondary Amount of pre-interventional comorbidities Number of comorbidities pre-interventional at baseline visit
Secondary Albumin and hematocrit level before intervention Optional assessment, only if done in the clinical routine pre-interventional at baseline visit
Secondary Number of falls in the last 6 months Number of falls per patient pre-interventional at baseline visit
Secondary Mini-Cog (for the cognitive status) Performance of the mini-cog test and analysis of the maximum points in this test pre-interventional at baseline visit
Secondary Pre-interventional timed "Up & Go" test Seconds to perform the up and go test will be measured pre-interventional at baseline visit
Secondary Comparison of the patients` outcomes across Europe Comparing the number of adverse outcomes between the hospitals and countries 30 days after intervention
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