Ignite Creation Date:
2024-05-06 @ 8:20 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06341816
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-23
First Post:
2024-03-20
Brief Title:
Treatment According to Venous Excess Ultrasound Score in Patients With Heart Failure
Sponsor:
Inonu University
Organization:
Inonu University
Study Overview
Official Title:
Regulation of Treatment According to Venous Load Ultrasound Score VEXUS in Patients Followed in Intensive Care Due to Heart Failure
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Heart failure is a syndrome that progresses with symptoms and signs caused by cardiac dysfunction and results in a shortened life expectancy 1 Acute heart failure resulting in hospitalization is a significant cause of morbidity and mortality With the increase in the severity of the disease and rapid advances in the treatment of heart failure these patients are frequently hospitalized and monitored in intensive care 2 Five years after diagnosis mortality can be up to 67 Additionally it is known that patients with heart failure are hospitalized on average once a year after diagnosis 3 In a multicenter study it constituted 14 of 3000 cardiac patients admitted to intensive care units Additionally due to longer ICU stays these patients accounted for 33 of total inpatient days An increasing number of heart failure patients require intensive care due to respiratory failure regardless of left ventricular ejection fraction Heart failure accounts for approximately one-third of patient days in intensive care units and this burden is increasing This shows that attention should be paid to the quality of care for patients requiring critical care 2 Multidisciplinary programs have been implemented to deal with the high prevalence However the optimal follow-up frequency is unknown Therefore some tools are needed to improve patient prognosis 3
Neutrophil gelatinase-associated lipocalin NGAL is a biomarker whose values in both urine and plasma have been associated with acute kidney injury AKI Although NGAL is an early specific biomarker for AKI it has not yet come into routine use but is frequently used in clinical and experimental studies 4
Venous load ultrasonography score VExUS is a new systemic congestion scoring method based on inferior vena cava dilation and pulsed wave Doppler PW-Doppler morphology of the hepatic portal and renal veins It has been proposed as a score to assess systemic congestion
Neutrophil gelatinase-associated lipocalin NGAL is a biomarker whose values in both urine and plasma have been associated with acute kidney injury AKI Although NGAL is an early specific biomarker for AKI it has not yet come into routine use but is frequently used in clinical and experimental studies 4
Venous load ultrasonography score VExUS is a new systemic congestion scoring method based on inferior vena cava dilation and pulsed wave Doppler PW-Doppler morphology of the hepatic portal and renal veins It has been proposed as a score to assess systemic congestion
Detailed Description:
Patients will be randomized according to the sealed envelope method While classical heart failure fluid management will be applied to patients in the conventional group diuretic treatment will be given to the vexus group in a way that will reduce the vexus score and the drugs and doses used in this treatment will be recorded
The development of acute renal failure in patients will be determined according to KDIGO criteria but confirmation will be made with NGAL
Patients will be divided into two groups those treated according to the VEXUS score and those treated simultaneously with VEXUS by a second experienced person INTENSIVE CARE SPECIALIST but treated conservatively Patients vital parameters complete blood count biochemistry coagulation arterial blood gas procalcitonin CRP troponin pro-BNP levels on Day 1 and Day 5 will be noted and distensibility will be detected by USG on Days 1 and 5 among those with an IVC diameter 2 cm or collapsibility index and for those 2cm VEXUS score will be calculated In addition EF TAPSE presence of pleural effusion or B-Line renal resistive index renal pulsatility index will be calculated
The development of acute renal failure in patients will be determined according to KDIGO criteria but confirmation will be made with NGAL
Patients will be divided into two groups those treated according to the VEXUS score and those treated simultaneously with VEXUS by a second experienced person INTENSIVE CARE SPECIALIST but treated conservatively Patients vital parameters complete blood count biochemistry coagulation arterial blood gas procalcitonin CRP troponin pro-BNP levels on Day 1 and Day 5 will be noted and distensibility will be detected by USG on Days 1 and 5 among those with an IVC diameter 2 cm or collapsibility index and for those 2cm VEXUS score will be calculated In addition EF TAPSE presence of pleural effusion or B-Line renal resistive index renal pulsatility index will be calculated
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None