University Hospital Duesseldorf
Düsseldorf, Germany
Location contact
Christian Jund, MD
CONTACT
Christian Jung, MD
PRINCIPAL_INVESTIGATOR
Lisa Dannenberg, MD
CONTACT
NCT Number: NCT07385482
Very old patients are a rapidly growing and vulnerable population in acute cardiovascular care but remain underrepresented in clinical trials. Clinical outcomes in older intensive care unit (ICU) patients are determined less by chronological age than by their clinical phenotype, including cardiovascular comorbidities, frailty, polypharmacy, and functional and cognitive impairment. This prospective multicenter observational study aims to assess the impact of chronic and acute cardiovascular diseases on long-term outcomes and functional trajectories in older ICU patients. Using the international VIP research network, approximately 4,000 patients will be enrolled across different ICU specialties and healthcare systems and assessed multidimensionally using validated clinical scores. The study seeks to improve risk stratification and outcome prediction in older critically ill patients with cardiovascular disease and to address existing evidence gaps in acute cardiovascular and intensive care medicine.
Trial opening soon.
Get Notified80 year and older
All sexes
Observational
Düsseldorf, Germany
Christian Jund, MD
CONTACT
Christian Jung, MD
PRINCIPAL_INVESTIGATOR
Lisa Dannenberg, MD
CONTACT
The primary aim of this prospective multicenter observational study is to investigate the impact of chronic and acute cardiovascular diseases on the clinical phenotype, short-term outcomes, and long-term functional trajectories of older intensive care unit (ICU) patients. The main hypothesis is that patients with chronic or acute cardiovascular diseases differ in their pre-ICU clinical phenotype and have a higher risk of adverse short-term outcomes and impaired long-term functional recovery compared with patients without these conditions. Using the established international VIP research network, older ICU patients will be assessed multidimensionally using validated instruments and routinely collected clinical data across different ICU specialties (cardiac, cardio-surgical, internal medicine, and surgical ICUs) and healthcare systems.
The primary endpoint of the study is 6-month all-cause mortality. Secondary endpoints include functional status and health-related quality of life during follow-up.
Pre-existing comorbidities will be captured using the AHRQ Elixhauser Comorbidity Index, with detailed documentation of chronic cardiovascular comorbidities and medication history. Frailty and functional status will be assessed using the Clinical Frailty Scale and the Katz Index, while baseline cognitive function will be evaluated using the Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE). Health-related quality of life prior to the acute illness will be assessed using the EQ-5D-5L. Nutritional status will be evaluated using the Geriatric Nutritional Risk Index (GNRI) and the Global Leadership Initiative on Malnutrition (GLIM) criteria (e.g. body weight and dietary history) At ICU admission and during the ICU stay, routinely available laboratory parameters including albumin, lactate, international normalized ratio (INR), HbA1c, and hemoglobin will be recorded. Disease severity will be assessed using the Sequential Organ Failure Assessment (SOFA) score at admission and during follow-up. Data on ICU interventions, including invasive mechanical ventilation, vasopressor therapy, renal replacement therapy, mechanical circulatory support, enteral and parenteral nutrition, and physiotherapy, will be documented. Hemoglobin levels at ICU admission and discharge as well as the highest and lowest values during the ICU stay will be captured.
Approximately 4,000 patients are planned to be enrolled within 12 months, allowing predefined subgroup analyses according to age, sex, frailty status, and cognitive function using advanced exploratory analytical approaches. The study aims to contribute to closing the existing evidence gap regarding chronic and acute cardiovascular disease in older critically ill patients
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: within 6 months
surivival or death
Time frame: 6 months
measured by clinical fraility scale: Scores range from 1 (Very Fit) to 9 (Terminally Ill). Higher scores indicate greater frailty and worse health status
Time frame: 6 months
measured by katz acitivies of daily living (assessment of ability to perform daily activities): Scores range from 0 to 6, with higher scores indicating greater independence and better functional status
Time frame: 6 months
measured by EQ-5D-5L (assessment of health-related quality of life): Individual response patterns will be reported as EQ-5D-5L health states (e.g., 11111 indicating no problems in all five dimensions), allowing a descriptive assessment of dimension-specific limitations
Time frame: up to 12 months
Long-term survival and readmission rate
Time frame: 6 months
Survival, Improvement or stability in frailty status according to the Clinical Frailty Scale compared to baseline, Improvement or stability in the ability to perform daily activities according to the Katz Activities of Daily Living compared to baseline, Improvement or stability in health-related quality of life according to the EQ-5D-5L compared to baseline.
Contact information is provided by the study sponsor or research team.
Christian Jung, MD
CONTACT
Lisa Dannenberg, MD
CONTACT
Heinrich-Heine University, Duesseldorf
Other
Impact of Chronic and Acute Cardiovascular Diseases in Older Intensive Care Patients: A Prospective Multicenter Observational Study - VIP4
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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