Ignite Creation Date:
2024-05-06 @ 7:55 PM
Last Modification Date:
2024-10-26 @ 3:16 PM
Study NCT ID:
NCT06180902
Status:
RECRUITING
Last Update Posted:
2024-01-17
First Post:
2023-12-11
Brief Title:
Comparing Fluid Responsiveness Assessment Methods in Patients With Impaired Consciousness
Sponsor:
Federal Research and Clinical Centre of Intensive Care Medicine and Rehabilitology
Organization:
Federal Research and Clinical Centre of Intensive Care Medicine and Rehabilitology
Study Overview
Official Title:
Comparing Fluid Responsiveness Assessment Methods in Patients With Impaired Consciousness A Comprehensive Crossover Study Examination
Status:
RECRUITING
Status Verified Date:
2024-01
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:
Hypotension is a significant precursor to unfavorable clinical outcomes To determine whether infusion therapy can positively impact the management of hypotension several evaluative tests can be utilized These include assessing the collapsibility and distensibility indices of the inferior vena cava conducting a passive leg raising PLR test and performing a fluid challenge FC
Technologically advanced methods leveraging dynamic testing are capable of real-time prediction of a patients response to infusion therapy Nonetheless the use of systolic pressure variability SPV pulse pressure variability PPV and stroke volume variability SVV is often limited by the prohibitive costs of the necessary equipment In contrast the PLR test and FC are not subject to this limitation
Despite being deemed unreliable by numerous clinical protocols static measurements of central venous pressure CVP or pulmonary capillary wedge pressure PCWP persist in usage among certain traditionalists within the medical community It must be noted that the patients baseline state and the unique clinical context are pivotal in determining the precision of these methodologies For example the PLR test may yield limited information in fully conscious patients and the prognostic value of CVP measurements is significantly diminished in cases of pneumothorax and hydrothorax
Regrettably there is a paucity of data on the prognostic utility of these tests in patients with altered levels of consciousness despite their growing presence in intensive care units This gap underscores the necessity for comprehensive studies that evaluate the predictive efficacy of infusion therapy responsiveness in patients with concurrent hypotension and impaired consciousness
Purpose of the study to investigate the sensitivity and specificity of methods for assessing fluid responsiveness in patients with hypotension and decreased level of consciousness
Technologically advanced methods leveraging dynamic testing are capable of real-time prediction of a patients response to infusion therapy Nonetheless the use of systolic pressure variability SPV pulse pressure variability PPV and stroke volume variability SVV is often limited by the prohibitive costs of the necessary equipment In contrast the PLR test and FC are not subject to this limitation
Despite being deemed unreliable by numerous clinical protocols static measurements of central venous pressure CVP or pulmonary capillary wedge pressure PCWP persist in usage among certain traditionalists within the medical community It must be noted that the patients baseline state and the unique clinical context are pivotal in determining the precision of these methodologies For example the PLR test may yield limited information in fully conscious patients and the prognostic value of CVP measurements is significantly diminished in cases of pneumothorax and hydrothorax
Regrettably there is a paucity of data on the prognostic utility of these tests in patients with altered levels of consciousness despite their growing presence in intensive care units This gap underscores the necessity for comprehensive studies that evaluate the predictive efficacy of infusion therapy responsiveness in patients with concurrent hypotension and impaired consciousness
Purpose of the study to investigate the sensitivity and specificity of methods for assessing fluid responsiveness in patients with hypotension and decreased level of consciousness
Detailed Description:
Hypotension often precedes adverse clinical outcomes prompting an investigation into the efficacy of infusion therapy in its management The study employs a variety of tests for assessment including evaluation of the inferior vena cavas collapsibility and distensibility indices passive leg raise PLR tests and fluid challenge FC procedures
Dynamic testing methods including systolic pressure variability SPV pulse pressure variability PPV and stroke volume variability SVV offer predictions of real-time responses to infusion therapy However the high costs of the necessary equipment restrict widespread application In contrast passive leg raise PLR and fluid challenge FC tests are more accessible due to lower costs
Despite skepticism in various clinical protocols regarding reliability traditional measures such as central venous pressure CVP and pulmonary capillary wedge pressure PCWP continue to be favored in certain medical circles Considering the patients baseline condition and specific clinical context is critical when applying such methods For instance the PLR test may be less informative in fully conscious patients and the value of CVP measurements decreases in cases like pneumothorax and hydrothorax
A notable deficiency exists in data concerning the prognostic value of tests in patients with altered consciousness levels a scenario frequently encountered in intensive care settings This situation underscores the urgent need for comprehensive research into the predictive accuracy of infusion therapy response in patients who have coexisting hypotension and impaired consciousness
The study aims to examine the sensitivity and specificity of fluid responsiveness assessment methods in hypotensive patients with reduced consciousness The protocol begins by measuring the diameter of the inferior vena cava followed by an evaluation of central venous pressure After a brief interval the passive leg raise PLR test is performed succeeded by a 15-minute waiting period Subsequently an infusion load test is carried out Next a balanced crystalloid solution of 1000 ml at a rate of 15 mlkgh is administered taking into account any previous infusions during the fluid challenge
In the study adherence to the intention-to-treat principle is planned for all analyses Data distribution will be assessed using the Kolmogorov-Smirnov test with Lilliefors correction or the Shapiro-Wilk test Descriptive data will be presented as percentages means SD for normally distributed variables or medians interquartile ranges for non-normally distributed variables Qualitative characteristics will be reported as frequencies P-values and confidence intervals will be provided for all comparative outcomes between two groups All statistical tests will be two-tailed with a significance threshold set at p 005
Outcomes for all binary variables including primary and secondary outcomes will be compared using the Chi-square test or Fishers exact test accounting for stratification variables Comparative intergroup analysis of quantitative variables will be based on the Mann-Whitney U test or Students t-test depending on data distribution characteristics Baseline data will include diagnostic test results such as true positives true negatives false positives and false negatives Diagnostic accuracy will be assessed using Area Under the Receiver Operating Characteristic curve AUROC and Area Under the Precision-Recall curve AUPC AUROC comparisons will be made using the DeLong method with the optimal cutoff in ROC analysis determined according to Youdens index Sensitivity specificity and predictive values of positive and negative results will also be evaluated Cohens Kappa will be used to assess test consistency
Dynamic testing methods including systolic pressure variability SPV pulse pressure variability PPV and stroke volume variability SVV offer predictions of real-time responses to infusion therapy However the high costs of the necessary equipment restrict widespread application In contrast passive leg raise PLR and fluid challenge FC tests are more accessible due to lower costs
Despite skepticism in various clinical protocols regarding reliability traditional measures such as central venous pressure CVP and pulmonary capillary wedge pressure PCWP continue to be favored in certain medical circles Considering the patients baseline condition and specific clinical context is critical when applying such methods For instance the PLR test may be less informative in fully conscious patients and the value of CVP measurements decreases in cases like pneumothorax and hydrothorax
A notable deficiency exists in data concerning the prognostic value of tests in patients with altered consciousness levels a scenario frequently encountered in intensive care settings This situation underscores the urgent need for comprehensive research into the predictive accuracy of infusion therapy response in patients who have coexisting hypotension and impaired consciousness
The study aims to examine the sensitivity and specificity of fluid responsiveness assessment methods in hypotensive patients with reduced consciousness The protocol begins by measuring the diameter of the inferior vena cava followed by an evaluation of central venous pressure After a brief interval the passive leg raise PLR test is performed succeeded by a 15-minute waiting period Subsequently an infusion load test is carried out Next a balanced crystalloid solution of 1000 ml at a rate of 15 mlkgh is administered taking into account any previous infusions during the fluid challenge
In the study adherence to the intention-to-treat principle is planned for all analyses Data distribution will be assessed using the Kolmogorov-Smirnov test with Lilliefors correction or the Shapiro-Wilk test Descriptive data will be presented as percentages means SD for normally distributed variables or medians interquartile ranges for non-normally distributed variables Qualitative characteristics will be reported as frequencies P-values and confidence intervals will be provided for all comparative outcomes between two groups All statistical tests will be two-tailed with a significance threshold set at p 005
Outcomes for all binary variables including primary and secondary outcomes will be compared using the Chi-square test or Fishers exact test accounting for stratification variables Comparative intergroup analysis of quantitative variables will be based on the Mann-Whitney U test or Students t-test depending on data distribution characteristics Baseline data will include diagnostic test results such as true positives true negatives false positives and false negatives Diagnostic accuracy will be assessed using Area Under the Receiver Operating Characteristic curve AUROC and Area Under the Precision-Recall curve AUPC AUROC comparisons will be made using the DeLong method with the optimal cutoff in ROC analysis determined according to Youdens index Sensitivity specificity and predictive values of positive and negative results will also be evaluated Cohens Kappa will be used to assess test consistency
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