Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06573112
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-01
Brief Title:
Central Venous Catheter-Related Thrombosis in Critically Ill Patients
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Incidence Factors Associated and Outcomes of Central Venous Catheter-Related Thrombosis in Critically Ill Patients a Prospective Cohort Study
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CVC-RT
Brief Summary:
This project aims to identify catheter-related thrombosis CRT and determine its incidence associated factors and outcomes The eligible patients will undergo daily ultrasound just distal to the central venous catheter insertion site for CRT A staff radiologist will review all positive cases These cases will be monitored by daily ultrasound examination till three days after the removal of the catheter or till the patient stays in the intensive care unit ICU The patient demographics ICU treatment details and outcomes will be noted The data will be then analyzed A preventive strategy will be prepared and disseminated to the department personnel to improve the quality of care
Detailed Description:
Central venous catheter CVC insertion is a common procedure for critically ill patients The CVCs are inserted on any site including the internal jugular subclavian brachio-cephalic and femoral veins The endothelium of the vein is injured with CVC placements and this predisposes to the formation of thrombus in addition to other predisposing factors like immobility thrombophilia reduced venous blood flow hypercoagulable state catheter material catheter diameter to vein diameter ratio CVC tip position etc The catheter fills up the lumen space intravenously thereby reducing blood flow inside the vein This slow flow state can predispose to thrombus formation
Peripherally inserted central catheters might have a higher incidence of CRT due to this reason CRT forms mostly at the insertion site frequently within the first week of catheterization The clinical manifestation of CRT can vary according to the size and site of the thrombus It is frequently asymptomatic however most patients develop signs and symptoms like edema pain erythema weakness and sometimes superficial venous circles Urschels sign If the vein involved with CRT is the superior vena cava of the anonymous vein there could be signs of superior vena cava SVC syndrome CRT is frequently evident with inadequate catheter flow As a consequence of CVC thrombus development at different sites and severity complications like deep vein thrombosis DVT extension compartment syndrome SVC syndrome catheter infection and permanent venous obstruction can develop Sometimes there can be the end-organ effect of the thrombus migration causing a pulmonary embolism PE ischemic stroke and embolism to the gut liver kidneys and heart These can significantly impact the patient outcome such as the length of stay in the ICU
Aim of the Study This research aims to study the incidence and associated factors including the initial catheter-to-vein diameter ratio and the outcomes of CRT at a tertiary-level university hospital in Oman With these data we will understand the condition and form a preventive strategy for CRT for critically ill patients
Methods This prospective study will include enrollment daily observation and follow-up of all patients undergoing a new CVC placement in the ICU After obtaining ethical approval the study will be registered at one of the registries Clinicaltrials platform All patients admitted to the ICU would be approached and those getting CVC placement would be given information about this research with the help of an information sheet All patientsor their relatives who consent to participate will be included during the study period Ultrasound assessment will be done on admission and every day till discharge from ICU or up to three days after CVC removal if in ICU
Ultrasound assessment This will involve examination of the central vein at and distal to the catheter site The examination will detect echogenic mass and compressibility in the vein as well as evaluate the color flow A diagnosis of CRT will be made if there is an echogenic mass and either incompressibility or absent color flow A radiologist will review all the positive cases Partial occlusion will be defined by partially occluding intraluminal echogenic filling defect and complete occlusion will be defined as intraluminal occluding thrombus with rounding and non-compressibility of vein and absence of color flow on Doppler In addition to the diagnosis the dimensions of the thrombus will be measured every day The outer diameter of the catheter and the catheter-vein diameter CVD ratio will be calculated on the day of CVC insertion The extraluminal hematoma will also be measured
Data collection Data like patient demographics co-morbidities severity of illness SOFA sequential organ failure assessment score investigations hemoglobin level platelet counts coagulation profile liver and renal dysfunction plasma protein levels calcium levels blood group etc catheterization details site and side of catheterization number of venous puncture attempt peri-venous hematomacollection CVD ratio at the start compressibility rounding of vein presence of color doppler flow treatment medications like antibiotics antiplatelets pro- thrombotic medications like tranexamic acid factor 7a vitamin D vitamin K intravenous immunoglobulin other regular ICU prophylaxis like DVT prophylaxis with unfractionated and fractionated heparin or other medications peptic ulcer prophylaxis with proton pump blockers medicationtotal parenteral nutrition with high osmolality etc in ICU Other routine ICU treatments with extracorporeal machines like continuous renal replacement therapyCRRT extracorporeal membrane oxygenation ECMO plasmapheresis intermittent hemodialysis length of stay in ICU outcomes like end organ thrombosis like ischemic stroke renalhepaticsplenicgutmyocardial infarction etc will be recorded prospectively in ICU and from electronic patient records from hospital information system after the discharge from ICU till hospital stay of the patient The ICU course record will also include the treatment procedures ventilator days infection details especially the catheter-related bloodstream infections and radiological assessment of the position of the tip of the catheter will all be recorded
Sample size
The sample size was estimated based on the anticipated cumulative incidence of CRT in an ICU population primary outcome The literature showed that the incidence ranges from 15-20 We expect around 500 ICU patients to be catheterized during the study period We anticipated a CRT incidence of 17 with a 3 absolute precision The confidence level was set at 95 Therefore the researcher has to study at least 274 admitted catheterized patients in the ICU The sample size was calculated using the OpenEpi web application httpswwwopenepicomSampleSizeSSProporhtm
Statistical analysis Continuous variables will be presented as mean median standard deviation and interquartile range whereas categorical variables will be presented as frequency and percentage The comparison of means between the two groups will be assessed using the independent samples t-test between two categorical variables will be tested using a Chi-square test Fishers exactLikelihood ratio The cumulative incidence of CRT will be reported with its 95 CI CRT incidence rate and 95 CI will be expressed as events1000 catheter days Univariate and multivariate Cox proportional hazards regression models will be fitted to calculate hazard ratios HR and 95 CI of CRT A P-value less than 005 will be considered statistically significant All the analyses will be performed using IBM SPSS Statistics IBM Corp Released 2022 IBM SPSS Statistics for Windows Version 290 Armonk NY IBM Corp
Peripherally inserted central catheters might have a higher incidence of CRT due to this reason CRT forms mostly at the insertion site frequently within the first week of catheterization The clinical manifestation of CRT can vary according to the size and site of the thrombus It is frequently asymptomatic however most patients develop signs and symptoms like edema pain erythema weakness and sometimes superficial venous circles Urschels sign If the vein involved with CRT is the superior vena cava of the anonymous vein there could be signs of superior vena cava SVC syndrome CRT is frequently evident with inadequate catheter flow As a consequence of CVC thrombus development at different sites and severity complications like deep vein thrombosis DVT extension compartment syndrome SVC syndrome catheter infection and permanent venous obstruction can develop Sometimes there can be the end-organ effect of the thrombus migration causing a pulmonary embolism PE ischemic stroke and embolism to the gut liver kidneys and heart These can significantly impact the patient outcome such as the length of stay in the ICU
Aim of the Study This research aims to study the incidence and associated factors including the initial catheter-to-vein diameter ratio and the outcomes of CRT at a tertiary-level university hospital in Oman With these data we will understand the condition and form a preventive strategy for CRT for critically ill patients
Methods This prospective study will include enrollment daily observation and follow-up of all patients undergoing a new CVC placement in the ICU After obtaining ethical approval the study will be registered at one of the registries Clinicaltrials platform All patients admitted to the ICU would be approached and those getting CVC placement would be given information about this research with the help of an information sheet All patientsor their relatives who consent to participate will be included during the study period Ultrasound assessment will be done on admission and every day till discharge from ICU or up to three days after CVC removal if in ICU
Ultrasound assessment This will involve examination of the central vein at and distal to the catheter site The examination will detect echogenic mass and compressibility in the vein as well as evaluate the color flow A diagnosis of CRT will be made if there is an echogenic mass and either incompressibility or absent color flow A radiologist will review all the positive cases Partial occlusion will be defined by partially occluding intraluminal echogenic filling defect and complete occlusion will be defined as intraluminal occluding thrombus with rounding and non-compressibility of vein and absence of color flow on Doppler In addition to the diagnosis the dimensions of the thrombus will be measured every day The outer diameter of the catheter and the catheter-vein diameter CVD ratio will be calculated on the day of CVC insertion The extraluminal hematoma will also be measured
Data collection Data like patient demographics co-morbidities severity of illness SOFA sequential organ failure assessment score investigations hemoglobin level platelet counts coagulation profile liver and renal dysfunction plasma protein levels calcium levels blood group etc catheterization details site and side of catheterization number of venous puncture attempt peri-venous hematomacollection CVD ratio at the start compressibility rounding of vein presence of color doppler flow treatment medications like antibiotics antiplatelets pro- thrombotic medications like tranexamic acid factor 7a vitamin D vitamin K intravenous immunoglobulin other regular ICU prophylaxis like DVT prophylaxis with unfractionated and fractionated heparin or other medications peptic ulcer prophylaxis with proton pump blockers medicationtotal parenteral nutrition with high osmolality etc in ICU Other routine ICU treatments with extracorporeal machines like continuous renal replacement therapyCRRT extracorporeal membrane oxygenation ECMO plasmapheresis intermittent hemodialysis length of stay in ICU outcomes like end organ thrombosis like ischemic stroke renalhepaticsplenicgutmyocardial infarction etc will be recorded prospectively in ICU and from electronic patient records from hospital information system after the discharge from ICU till hospital stay of the patient The ICU course record will also include the treatment procedures ventilator days infection details especially the catheter-related bloodstream infections and radiological assessment of the position of the tip of the catheter will all be recorded
Sample size
The sample size was estimated based on the anticipated cumulative incidence of CRT in an ICU population primary outcome The literature showed that the incidence ranges from 15-20 We expect around 500 ICU patients to be catheterized during the study period We anticipated a CRT incidence of 17 with a 3 absolute precision The confidence level was set at 95 Therefore the researcher has to study at least 274 admitted catheterized patients in the ICU The sample size was calculated using the OpenEpi web application httpswwwopenepicomSampleSizeSSProporhtm
Statistical analysis Continuous variables will be presented as mean median standard deviation and interquartile range whereas categorical variables will be presented as frequency and percentage The comparison of means between the two groups will be assessed using the independent samples t-test between two categorical variables will be tested using a Chi-square test Fishers exactLikelihood ratio The cumulative incidence of CRT will be reported with its 95 CI CRT incidence rate and 95 CI will be expressed as events1000 catheter days Univariate and multivariate Cox proportional hazards regression models will be fitted to calculate hazard ratios HR and 95 CI of CRT A P-value less than 005 will be considered statistically significant All the analyses will be performed using IBM SPSS Statistics IBM Corp Released 2022 IBM SPSS Statistics for Windows Version 290 Armonk NY IBM Corp
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None