Ignite Creation Date:
2024-06-16 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06434987
Status:
RECRUITING
Last Update Posted:
2024-05-30
First Post:
2024-05-15
Brief Title:
Impact of RIVP on GI Function in Patients Undergoing Surgical Repair for ATAAD
Sponsor:
The Second Hospital of Nanjing Medical University
Organization:
The Second Hospital of Nanjing Medical University
Study Overview
Official Title:
Impact of Retrograde Inferior Vena Cava Perfusion on Gastrointestinal Function in Patients Undergoing Surgical Repair for Acute Type A Aortic Dissection A Study Protocol and Prospective Evaluation
Status:
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:
Acute Type A Aortic Dissection ATAAD is a serious medical condition that requires immediate surgical intervention The repair of Acute Type A Aortic Dissection ATAAD combines different surgical procedures including the use of Cardiopulmonary Bypass CPB This study focuses on the gastrointestinal GI system and the complications arising in the gastrointestinal GI system as a result of this procedure Retrograde Inferior Vena Cava Perfusion RIVP is a technique used during Cardiopulmonary Bypass CPB that could show potential in mitigating latent gastrointestinal GI complications The study aims to evaluate the effectiveness of Retrograde Inferior Vena Cava Perfusion RIVP in patients receiving Acute Type A Aortic Dissection ATAAD repair with Cardiopulmonary Bypass CPB in reducing Ischemic Reperfusion IR injury and inflammatory responses that affect gastrointestinal GI integrity It intends to compare the postoperative gastrointestinal GI complications and long-term gastrointestinal GI function between patients treated with Antegrade Cerebral Perfusion ACP and Retrograde Inferior Vena Cava Perfusion RIVP and those treated with Antegrade Cerebral Perfusion ACP alone The patients will be placed in their respective groups as per the decision of the surgeons perfusionists and the condition of the patient Data collection will be facilitated by a comprehensive Case Report Form CRF This pilot study guided by established methodologies places the studys sample size at 30 to ensure statistical reliability and prevent resource wastage Through this approach of sample collection baseline data collection peri-operative data recording and follow-up assessments the study aims to shed light on the impact of Retrograde Inferior Vena Cava Perfusion RIVP during Acute Type A Aortic Dissection ATAAD repair on gastrointestinal GI complications and systemicintestinal inflammation The integration of specialized Case Report Forms CRFs and structured questionnaires ensures standardized data collection and management while prioritizing patient confidentiality The studys data analysis powered by R software will provide valuable insights into the efficacy of Retrograde Inferior Vena Cava Perfusion RIVP in enhancing clinical outcomes and improving patients prognosis in the surgical treatment of Acute Type A Aortic Dissection ATAAD
Detailed Description:
Retrograde Inferior Vena Cava Perfusion RIVP is a adjunct technique used in surgery during the repair of Acute Type A Aortic Dissection ATAAD This procedure generally involves perfusing oxygenated blood into the inferior vena cava directing it toward the visceral organs and lower extremities This technique plays an important role in reducing the risk of ischemic injury to these vital regions during deep hypothermic circulatory arrest DHCA when combined with Antegrade Cerebral Perfusion ACP
Recent study showed that the use of Retrograde Inferior Vena Cava Perfusion RIVP in conjunction with Antegrade Cerebral Perfusion ACP may lead to lower rates of organ dysfunction in the lower body reduced mortality and shorter Cardiopulmonary Bypass CPB duration It has also been associated with maintaining higher higher body temperature during circulatory arrest which may be beneficial for the overall patient well-being
However despite these promising results there is a need for further research to explore the scientific impact of Retrograde Inferior Vena Cava Perfusion RIVP on gastrointestinal function during and after Acute Type A Aortic Dissection ATAAD repair Gastrointestinal complications are a crucial aspect of a patients outcomes and more often neglected Understanding the relationship between Retrograde Inferior Vena Cava Perfusion RIVP and these complications may be essential and have the potential to lead better prognosis among patients resulting in improved outcomes
In summary Retrograde Inferior Vena Cava Perfusion RIVP is a valuable technique that helps protect abdominal organs and lower extremities during Acute Type A Aortic Dissection ATAAD surgery While it shows promise in improving patient outcomes ongoing research is necessary to comprehensively assess its effect on gastrointestinal function thus optimizing its use in the surgical management of Acute Type A Aortic Dissection ATAAD
This study is designed as a single centered prospective cohort study with an exploratory framework The study will be conducted at the Second Affiliated Hospital of Nanjing Medical University Cardiovascular Center This study will focus on patients undergoing Acute Type A Aortic Dissection ATAAD repair with or without Retrograde Inferior Vena Cava Perfusion RIVP Patients will be assigned to these groups based on surgical and patient specific criteria in the ratio 11 and will follow patients in the Cardiovascular Critical Care Unit CCU pre-operatively Group A will receive selective ACPRIVP while group B will receive ACP alone under mild to moderate hypothermia As per the general rule of thumb the study anticipates to recruit up to 30 patients for the pilot study in total 15 in each group
Patients will undergo diagnostic assessments to confirm diagnosis of Acute Type A Aortic Dissection ATAAD and depending on urgency they will proceed either to surgery or Cardiovascular Critical Care Unit CCU Informed consent will be obtained but this will in no way delay the treatment protocol for the patients In case of urgent surgery a surgical fellow will obtain the consent Patients can withdraw without repercussions and no replacements will be sought
All data will be collected and recorded systematically in a well drafted case report form A protocol has been written to conduct this study and we have followed the SPIRITS guidelines Any changes in the protocol will be timely reported and adjusted
We will collect blood samples at specific time intervals pre operatively PO1 post operatively day 1 PO2 day 3 PO3 day 7 PO4 The study will include biomarker evaluation CRP intestinal barrier indicators D-amine oxidaseDAO Fatty Acid Binding Protein 2 FABP2 D-Lactate Endotoxins and 12 cytokine panel
All baseline data ranging from clinical parameters anthropometric data baseline gastrointestinal GI assessment and clinical data will be obtained before surgery and recorded in the case report form
Peri operative data duration of Cardiopulmonary Bypass CPB duration of deep hypothermic circulatory arrest DHCA cross clamp time surgery time number of units of whole blood fresh frozen plasma pooled platelets and cryoprecipitate administered will be collected within the surgical room by the perfusionist and the anesthesiologist
A prospective longitudinal study will assess long term gastrointestinal GI dysfunction post surgery through follow up methods such as outpatient Wechat application in hospital or telephone based follow up evaluation at specified intervals 13612 months post hospital discharge A meticulously drafted questionnaire will be used as a tool for assessment
To establish presence of gut barrier dysfunction the investigators will look at the specific patterns or deviation in values of the biomarkers from the normal or baseline levels An increase in pro-inflammatory cytokines may suggest an inflammatory response associated with gut barrier dysfunction Elevated levels of D- Lactate Fatty Acid Binding Protein 2 FABP2 and endotoxins and decreased activity levels of D-amine oxidase DAO could suggest gut barrier dysfunction
The investigators will perform comprehensive statistical analysis to evaluate continuous variables like inflammatory markers This includes calculating the mean standard deviation and interquartile range for values related to C- reactive protein CRP cytokines and intestinal barrier markers The investigators will use the t-test to analyze differences in these variables For ordinal data from the Case Report Form CRF and follow up questionnaire wilcoxon rank sun test for hypothesis testing will be used Categorical data will be presented as percentages and the differences in these categories will be assessed using the chi-squared test To handle data at multiple time points ANOVA will be used to assess variance When dealing with multiple dependant variables like various cytokine levels simultaneously the investigators will employ a multivariate analysis of variance We will consider results statistically significant if the p value is 005 in lone with established research and data analysis practices
Recent study showed that the use of Retrograde Inferior Vena Cava Perfusion RIVP in conjunction with Antegrade Cerebral Perfusion ACP may lead to lower rates of organ dysfunction in the lower body reduced mortality and shorter Cardiopulmonary Bypass CPB duration It has also been associated with maintaining higher higher body temperature during circulatory arrest which may be beneficial for the overall patient well-being
However despite these promising results there is a need for further research to explore the scientific impact of Retrograde Inferior Vena Cava Perfusion RIVP on gastrointestinal function during and after Acute Type A Aortic Dissection ATAAD repair Gastrointestinal complications are a crucial aspect of a patients outcomes and more often neglected Understanding the relationship between Retrograde Inferior Vena Cava Perfusion RIVP and these complications may be essential and have the potential to lead better prognosis among patients resulting in improved outcomes
In summary Retrograde Inferior Vena Cava Perfusion RIVP is a valuable technique that helps protect abdominal organs and lower extremities during Acute Type A Aortic Dissection ATAAD surgery While it shows promise in improving patient outcomes ongoing research is necessary to comprehensively assess its effect on gastrointestinal function thus optimizing its use in the surgical management of Acute Type A Aortic Dissection ATAAD
This study is designed as a single centered prospective cohort study with an exploratory framework The study will be conducted at the Second Affiliated Hospital of Nanjing Medical University Cardiovascular Center This study will focus on patients undergoing Acute Type A Aortic Dissection ATAAD repair with or without Retrograde Inferior Vena Cava Perfusion RIVP Patients will be assigned to these groups based on surgical and patient specific criteria in the ratio 11 and will follow patients in the Cardiovascular Critical Care Unit CCU pre-operatively Group A will receive selective ACPRIVP while group B will receive ACP alone under mild to moderate hypothermia As per the general rule of thumb the study anticipates to recruit up to 30 patients for the pilot study in total 15 in each group
Patients will undergo diagnostic assessments to confirm diagnosis of Acute Type A Aortic Dissection ATAAD and depending on urgency they will proceed either to surgery or Cardiovascular Critical Care Unit CCU Informed consent will be obtained but this will in no way delay the treatment protocol for the patients In case of urgent surgery a surgical fellow will obtain the consent Patients can withdraw without repercussions and no replacements will be sought
All data will be collected and recorded systematically in a well drafted case report form A protocol has been written to conduct this study and we have followed the SPIRITS guidelines Any changes in the protocol will be timely reported and adjusted
We will collect blood samples at specific time intervals pre operatively PO1 post operatively day 1 PO2 day 3 PO3 day 7 PO4 The study will include biomarker evaluation CRP intestinal barrier indicators D-amine oxidaseDAO Fatty Acid Binding Protein 2 FABP2 D-Lactate Endotoxins and 12 cytokine panel
All baseline data ranging from clinical parameters anthropometric data baseline gastrointestinal GI assessment and clinical data will be obtained before surgery and recorded in the case report form
Peri operative data duration of Cardiopulmonary Bypass CPB duration of deep hypothermic circulatory arrest DHCA cross clamp time surgery time number of units of whole blood fresh frozen plasma pooled platelets and cryoprecipitate administered will be collected within the surgical room by the perfusionist and the anesthesiologist
A prospective longitudinal study will assess long term gastrointestinal GI dysfunction post surgery through follow up methods such as outpatient Wechat application in hospital or telephone based follow up evaluation at specified intervals 13612 months post hospital discharge A meticulously drafted questionnaire will be used as a tool for assessment
To establish presence of gut barrier dysfunction the investigators will look at the specific patterns or deviation in values of the biomarkers from the normal or baseline levels An increase in pro-inflammatory cytokines may suggest an inflammatory response associated with gut barrier dysfunction Elevated levels of D- Lactate Fatty Acid Binding Protein 2 FABP2 and endotoxins and decreased activity levels of D-amine oxidase DAO could suggest gut barrier dysfunction
The investigators will perform comprehensive statistical analysis to evaluate continuous variables like inflammatory markers This includes calculating the mean standard deviation and interquartile range for values related to C- reactive protein CRP cytokines and intestinal barrier markers The investigators will use the t-test to analyze differences in these variables For ordinal data from the Case Report Form CRF and follow up questionnaire wilcoxon rank sun test for hypothesis testing will be used Categorical data will be presented as percentages and the differences in these categories will be assessed using the chi-squared test To handle data at multiple time points ANOVA will be used to assess variance When dealing with multiple dependant variables like various cytokine levels simultaneously the investigators will employ a multivariate analysis of variance We will consider results statistically significant if the p value is 005 in lone with established research and data analysis practices
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