NCT02893657|Unknown
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Sponsor study identifier
observational
150
1 country
1
Study Start
December 1, 2017
Actual (reported)Primary Completion
May 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
May 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
The aim of the present study is the evaluation of the occurrence and effect of hepatic dysfunction on outcome following cardiac surgery, as well as the monitoring of changes in liver haemodynamics in the early postoperative period.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 30, 2016
Actual (reported)September 8, 2016
Actual (reported)December 1, 2017
Actual (reported)May 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
May 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
The composite of in-hospital death of any cause
Participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Length of hospital stay
Participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Length of ICU stay
Participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Evidence of clinically definite postoperative decline in hepatic function
Participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Need for reoperation due to bleeding or cardiac cause
Participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Evidence of clinically definite postoperative pulmonary or systemic congestion
Participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Evidence of clinically definite postoperative low cardiac output syndrome
Participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Evidence of clinically definite postoperative acute kidney injury and the need for dialysis
Participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Adult cardiac surgical patients
Heart and Vascular Center, Semmelweis University
Budapest, 1122, Hungary
Enikő Holndonner-Kirst, MD
Semmelweis University
Andrea Székely, MD, PhD
Semmelweis University
Daniel Lex, MD
Semmelweis University
Nikoletta Ráhel Czobor, MD
Semmelweis University
First Submitted
August 30, 2016
First Posted
September 8, 2016
Study Start
December 1, 2017
Actual (reported)Primary Completion
May 2022
Estimated (date passed)Optimal Balance Alfapump® System Feasibility Study
Contact the study team to confirm eligibility.
Ádám Nagy, MD
Semmelweis University
János Gál, MD, PhD
Semmelweis University
Béla Merkely, MD, PhD
Semmelweis University
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
May 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
January 11, 2022
Record last verified: 2022-01
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Source: ClinicalTrials.gov.
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