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The Role of Concomitant Diseases in Postoperative Complications Risk Stratification. (STOPRISK)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03945968
Recruitment Status : Recruiting
First Posted : May 10, 2019
Last Update Posted : April 27, 2022
Sponsor:
Collaborator:
Kuban State Medical University
Information provided by (Responsible Party):
Igor Zabolotskikh, Russian Federation of Anesthesiologists and Reanimatologists

Brief Summary:
Study is conducted to assess the prevalence and structure of comorbidity among patients undergoing abdominal surgery and produce the stratification of the risk of postoperative complications by identifying independent predictors for its development.

Condition or disease
Coronary Heart Disease Anemia Bronchial Asthma Stroke Epilepsy Parkinson's Disease Heart Rhythm Disorders Alzheimer's Disease Neuromuscular Diseases Diabetes Chronic Heart Failure Chronic Obstructive Pulmonary Disease Chronic Kidney Diseases

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Study Type : Observational
Estimated Enrollment : 16000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Role of Concomitant Diseases in Postoperative Complications Risk Stratification - a Prospective Observational Multi-center Cohort Study
Actual Study Start Date : July 1, 2019
Estimated Primary Completion Date : December 30, 2022
Estimated Study Completion Date : February 28, 2023





Primary Outcome Measures :
  1. incidence of postoperative complications [ Time Frame: 7 days after surgery ]

    Postoperative complications (according to the definitions of ESA-SCICM, 2015)

    1. Acute kidney damage
    2. ARDS
    3. The failure of the anastomose
    4. Arrhythmias
    5. Cardiac arrest
    6. Cardiogenic pulmonary edema
    7. Postoperative delirium
    8. Myocardial infarction
    9. Pneumonia
    10. Paresis of the intestine
    11. Postoperative bleeding
    12. Pulmonary thromboembolism
    13. Stroke
    14. Wound infection


Secondary Outcome Measures :
  1. mortality after abdominal surgery [ Time Frame: 30 days ]
    30-day mortality


Biospecimen Retention:   Samples Without DNA
whole blood, serum, white cells, albumin, erythrocytes, thromocytes


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Adult atients undergoing an abdominal surgery in study centers
Criteria

Inclusion Criteria:

  • surgical interventions on the abdominal organs,
  • 1-3 ASA physical status class

Exclusion Criteria:

  • the inability to assess the factors included in the study,
  • acute massive blood loss, aspiration,
  • bronchospasm,
  • anaphylactic reactions,
  • malignant hyperthermia

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03945968


Contacts
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Contact: Nikita Trembach, PhD +79528589299 nikitkax@mail.ru
Contact: Igor Zabolotskikh, MD pobeda_zib@mail.ru

Locations
Show Show 32 study locations
Sponsors and Collaborators
Russian Federation of Anesthesiologists and Reanimatologists
Kuban State Medical University
Investigators
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Principal Investigator: Igor Zabolotskikh, MD Russian Federation of Anesthesiologists and Reanimatologists
Publications:

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Responsible Party: Igor Zabolotskikh, Head of guidelines and clinical stгdies commettee, Russian Federation of Anesthesiologists and Reanimatologists
ClinicalTrials.gov Identifier: NCT03945968    
Other Study ID Numbers: FARCT0001
First Posted: May 10, 2019    Key Record Dates
Last Update Posted: April 27, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Igor Zabolotskikh, Russian Federation of Anesthesiologists and Reanimatologists:
anesthesia
concomitant diseases
risk stratification
Additional relevant MeSH terms:
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Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Asthma
Parkinson Disease
Alzheimer Disease
Neuromuscular Diseases
Kidney Diseases
Renal Insufficiency, Chronic
Heart Diseases
Coronary Disease
Arrhythmias, Cardiac
Postoperative Complications
Cardiovascular Diseases
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Synucleinopathies
Neurodegenerative Diseases
Lung Diseases
Respiratory Tract Diseases
Dementia
Tauopathies
Neurocognitive Disorders
Mental Disorders
Urologic Diseases
Renal Insufficiency
Myocardial Ischemia