Periinterventional Outcome Study in the Elderly

Mortality Clinical Trial

— POSE  

Official title:

Periinterventional Outcome Study in the Elderly (POSE): European, Multi-centre, Prospective Observational Cohort Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03152734
• Other study ID #: 17-070
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Complication, Postoperative
• Mortality
• Postoperative Complications

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