Clinical trial NCT03379688: PDMS Outcome After Intensive Care, Organdysfunction and Monitoring
Official title: Patient Data Management System Monitored Outcome After Intensive Care, Organdysfunction and Monitoring
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pleural Effusion
Blood Pressure
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2017-12-20
Enrollment: 6909
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All adult male and female patients who have undergone cardiac surgery in the period 01/06-12/13 at Campus Mitte in the Charité, approx. 7000 patients.

Brief summary: The objective of the explorative registry study is to investigate outcome parameters in the routine treatment of patients who are monitored after heart surgery for either short or long-term treatment in the intensive care unit for close monitoring of blood pressure.

Detailed description: The close monitoring of patients after cardiac surgery is regarded as standard. However, little is currently known about the influence on patient-related outcome parameters. Recently it has already been shown that intraoperative variability of blood pressure during heart surgery has a postoperative effect on 30-day mortality.

The aim of this retrospective study is to investigate the effects of different hemodynamic measurements and management after cardiac surgery on patient-specific outcome parameters.

Eligibility criteria: Inclusion Criteria:

1. In-patients of the Charité Universitätsmedizin Berlin
2. at least 18 years old
3. female or male sex
4. cardiosurgical intervention (OPS 5.35 and 5.36) between 01/06 and 12/13.
5. post-operative monitoring of anesthesiological intensive care unit

Exclusion Criteria:

1. previous cardiosurgical interventions during the same hospital stay.
2. incomplete documentation

Primary outcomes:
measure: Blood pressure in range
timeFrame: Intensive Care stay, an average of 10 days
measure: Blood pressure over range
timeFrame: Intensive Care stay, an average of 10 days
measure: Blood pressure below range
timeFrame: Intensive Care stay, an average of 10 days
Secondary outcomes:
measure: Hospital stay
timeFrame: an average of 13 days
measure: ICU stay
timeFrame: an average of 5 days
measure: ICU readmission
timeFrame: an average of 30 days
measure: Renal insufficiency - 1
timeFrame: intensive care unit stay, an average of 5 days
measure: Renal insufficiency - 2
timeFrame: intensive care unit stay, an average of 5 days
measure: Renal insufficiency - 3
timeFrame: intensive care unit stay, an average of 5 days
measure: Stroke
timeFrame: hospital length of stay, an average of 13 days
measure: Drainage loss
timeFrame: intensive care unit stay, an average of 5 days
measure: transfusions
timeFrame: hospital length of stay, an average of 13 days
measure: mortality rate-1
timeFrame: 90 days
measure: mortality rate-2
timeFrame: 180 days
measure: Pulse Contour Cardiac Output
timeFrame: intensive care unit stay, an average of 5 days
measure: mortality rate-3
timeFrame: 5 years
measure: mortality rate-4
timeFrame: 1 year
measure: Central venous pressure
timeFrame: intensive care unit stay, an average of 5 days
measure: Pleural effusion
timeFrame: hospital length of stay, an average of 13 days
measure: Case cost
timeFrame: hospital length of stay, an average of 13 days
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charité Universitätsmedizin Berlin
Study officials:
affiliation: Charite University, Berlin, Germany
name: Felix Balzer, MD; PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Carl M, Alms A, Braun J, Dongas A, Erb J, Goetz A, Goepfert M, Gogarten W, Grosse J, Heller AR, Heringlake M, Kastrup M, Kroener A, Loer SA, Marggraf G, Markewitz A, Reuter D, Schmitt DV, Schirmer U, Wiesenack C, Zwissler B, Spies C. S3 guidelines for intensive care in cardiac surgery patients: hemodynamic monitoring and cardiocirculary system. Ger Med Sci. 2010 Jun 15;8:Doc12. doi: 10.3205/000101.
citation: Aronson S, Stafford-Smith M, Phillips-Bute B, Shaw A, Gaca J, Newman M; Cardiothoracic Anesthesiology Research Endeavors. Intraoperative systolic blood pressure variability predicts 30-day mortality in aortocoronary bypass surgery patients. Anesthesiology. 2010 Aug;113(2):305-12. doi: 10.1097/ALN.0b013e3181e07ee9.
citation: Aronson S, Dyke CM, Levy JH, Cheung AT, Lumb PD, Avery EG, Hu MY, Newman MF. Does perioperative systolic blood pressure variability predict mortality after cardiac surgery? An exploratory analysis of the ECLIPSE trials. Anesth Analg. 2011 Jul;113(1):19-30. doi: 10.1213/ANE.0b013e31820f9231. Epub 2011 Feb 23.