Effects of Positive End-expiratory Pressure and Tidal Volume on Fluid Responsiveness of Acute Respiratory Distress Syndrome
| Tracking Information | |||||
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| First Received Date ICMJE | October 26, 2012 | ||||
| Last Updated Date | November 30, 2012 | ||||
| Start Date ICMJE | November 2012 | ||||
| Estimated Primary Completion Date | July 2014 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
increase of cardiac output after volume expansion [ Time Frame: 4 hours ] [ Designated as safety issue: No ] Patients are classified to be volume expansion responders or nonresponders according to whether the volume expansion induced cardiac index increase at the end of hydroxyethyl starch infusion is ≧15% or < 15% of baseline cardiac index. |
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| Original Primary Outcome Measures ICMJE |
increase of cardiac output after volume expansion [ Time Frame: 4 hours ] [ Designated as safety issue: No ] Patients are classified to be VE responders or nonresponders according to whether the VE-induced CI increase at the end of HES infusion is ≧15% or < 15% of baseline CI. |
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| Change History | Complete list of historical versions of study NCT01716962 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Effects of Positive End-expiratory Pressure and Tidal Volume on Fluid Responsiveness of Acute Respiratory Distress Syndrome | ||||
| Official Title ICMJE | Effects of Positive End-expiratory Pressure and Tidal Volume on Fluid Responsiveness of Acute Respiratory Distress Syndrome. | ||||
| Brief Summary | Fluid responsiveness (FR)refers to the ability of heart to increase its stroke volume in response to volume load.Low tidal volume and high PEEP exerts contrast effect on the prediction of fluid responsiveness, the aim of this study is to compare the relative predicting power of the dynamic preload indicator (PPV, SVV), passive leg raising test, and pleth variability index (PVI) on the fluid responsiveness of acute respiratory distress syndrome ventilated with various PEEP levels or various tidal volumes. |
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| Detailed Description | In septic critically ill mechanically ventilated patients with acute circulatory failure, inadequate volume resuscitation leads to multiple organ failure. Early goal-directed therapy emphasizes early and aggressive hemodynamic support in patients with severe sepsis and septic shock. On the other hand, because of increased microvascular permeability and capillary leakage, conservative fluid management and more aggressive restriction in fluid accumulation to reduce lung water and tissue edema has been suggested by acute respiratory distress syndrome net. Fluid responsiveness refers to the ability of the heart to increase its stroke volume in response to volume load. Accurately predicting volume responsiveness will be beneficial in obviating the need for unnecessary fluid loading, and in detecting patients who may benefit from a volume load. By inducing cyclic changes in pleural and transpulmonary pressure, mechanical ventilation results in cyclic changes in the preload and afterload, and therefore, the cyclic variation in systolic and pulse pressure. Recently, a systemic review concluded that dynamic preload indicator [pulse pressure variation (PPV), stroke volume variation (SVV)] are highly accurate in predicting volume responsiveness in critically ill patients. However, this technique is limited to patients who receive controlled ventilation with adequate tidal volume (> 8 ml/Kg) and sedation or paralysis is needed to abolish the spontaneous ventilation. For acute respiratory distress syndrome patients, protective ventilatory strategy suggested low tidal volume to 6 ml/Kg. On the contrary, high PEEP needed for acute respiratory distress syndrome to prevent VALI induces a leftward shift to the steep pat of the Frank-Starling curve and increase the fluid responsiveness. Whether the dynamic preload indicators (PPV and SVV) are still effective in acute respiratory distress syndrome patients for predicting fluid responsiveness remain controversial. Passive leg raising (PLR), by inducing a gravitational transfer of blood from the lower part of the body toward the central circulatory compartment, can be considered as a brief "self volume challenge". Recently, a systemic review and meta-analysis concluded that PLR-induced changes in cardiac output reliably predict fluid responsiveness regardless of ventilation mode, underlying cardiac rhythm and technique of measurement and can be recommended for routine assessment of fluid responsiveness in the majority of ICU population. More importantly, this prediction remains very valuable in patients with cardiac arrhythmias or spontaneous breathing activity. Respiratory variations in the pulse oximeter plethysmographic waveform amplitude (ΔPOP) have been shown to be able to predict fluid responsiveness in mechanically ventilated patients. The main advantage of this index is that it is noninvasive, widely available, and inexpensive. Perfusion index (PI), the percentage between the infrared pulsatile and nonpulsatile signal, reflects the amplitude of the pulse oximeter waveform. Recently, Pleth Variability Index (PVI), derived from perfusion index, affords a continuous monitoring of ΔPOP. PVI has been shown to be correlated to ΔPOP and PPV and has been demonstrated to be equivalent to SVV as a predictor of fluid responsiveness in ventilated patients during major surgery. However, whether the PVI can predict the fluid responsiveness in acute respiratory distress syndrome necessitating low tidal volume and high PEEP is not clear. Because of the aforementioned contrasting effects of low tidal volume and high PEEP on the prediction of fluid responsiveness, the aim of this study is to compare the relative predicting power of the dynamic preload indicator (PPV, SVV), passive leg raising test, and PVI on the fluid responsiveness of acute respiratory distress syndrome ventilated with various PEEP levels or various tidal volumes. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Probability Sample | ||||
| Study Population | mechanically ventilated ALL/ARDS patients conforming to the American European Consensus Conference criteria with acute circulatory failure for whom the attending clinician had decided to administer fluid will be enrolled.This decision was based on the presence of at least one clinical sign of inadequate tissue perfusion in the absence of contraindication for fluid infusion. |
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| Condition ICMJE | Respiratory Distress Syndrome, Adult | ||||
| Intervention ICMJE | Other: Infusion of 6% tetrastarch for a total of 500 ml | ||||
| Study Group/Cohort (s) | ARDS with acute circulatory failure
acute respiratory distress syndrome with acute circulatory failure with infusion of 6% tetrastarch for a total of 500ml
Intervention: Other: Infusion of 6% tetrastarch for a total of 500 ml |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Not yet recruiting | ||||
| Estimated Enrollment ICMJE | 30 | ||||
| Completion Date | Not Provided | ||||
| Estimated Primary Completion Date | July 2014 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria: Clinical signs of inadequate tissue perfusion were defined
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Not Provided | ||||
| Location Countries ICMJE | Taiwan | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01716962 | ||||
| Other Study ID Numbers ICMJE | CGMF IRB 100-4473A3 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Huang chung chi, Chang Gung Memorial Hospital | ||||
| Study Sponsor ICMJE | Chang Gung Memorial Hospital | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Chang Gung Memorial Hospital | ||||
| Verification Date | November 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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