Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Fluid management is one of the key issues in the initial management of septic shock (SS). Fluid overload and hypovolemia have been associated with increased mortality in several trials. Transthoracic echocardiography (TTE) and lung ultrasound are recommended for haemodynamic assessment in critically ill patients. However, the benefit of hemodynamic optimisation using echography has not been yet evaluated. The purpose of this multicenter, controlled, randomized trial is to assess the impact of an echocardiographic algorithm of hemodynamic optimization on fluid management in septic patients during the first 4 days of therapy.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Interventional Strategy: STOPFLUID Algorithm | Experimental | Fluid management is optimised using the specific echographic hemodynamic algorithm ('STOPFLUID') of this study described during the first 4 days of septic shock. Fluid bolus will not be administered in case of increased left ventricle filling pressures; fluid challenge will be performed based on dynamic indices and fluid depletion will be considered on the basis of Lung UltraSound (LUS) assessment. |
|
| Standard Strategy | No Intervention | Fluid management will be handled according to standard care, without using transthoracic echocardiography (TTE) during the first 4 days of septic shock management. Haemodynamic monitoring including pulmonary artery catheter, transpulmonary thermodilution, or any other device will be left at the physician's discretion. TTE will be allowed in the standard group only for excluding cardiac tamponade in case of clinical suspicion (one or more of the following signs: jugular distension, pulsus paradoxus) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Echographic hemodynamic algorithm guiding fluid resuscitation | Other | Ultrasound Hemodynamic Algorithm (UHA):
|
| Measure | Description | Time Frame |
|---|---|---|
| Volume of vascular filling during the first 4 days | This takes into account the cumulative volume of vascular filling administered to improve cardiac output during the 4 first days, measured in Liter (L) | Day 4 |
| Measure | Description | Time Frame |
|---|---|---|
| .Analysis of the primary endpoint related to ARDS ([acute respiratory distress syndrome, according to Berlin criteria) | Analysis of the primary endpoint in relation with presence or absence of ARDS at inclusion | Day 4 |
| Analysis of the primary endpoint related to severe renal dysfunction |
Not provided
All eligible patients will have a cardiac echocardiogram prior to inclusion for the sole purpose of eliminating special situations that are part of the non-inclusion criteria listed below.
Inclusion Criteria
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Claire Roger | CHU Nimes | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Nimes | Nîmes | 30029 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22738085 | Background | Perner A, Haase N, Guttormsen AB, Tenhunen J, Klemenzson G, Aneman A, Madsen KR, Moller MH, Elkjaer JM, Poulsen LM, Bendtsen A, Winding R, Steensen M, Berezowicz P, Soe-Jensen P, Bestle M, Strand K, Wiis J, White JO, Thornberg KJ, Quist L, Nielsen J, Andersen LH, Holst LB, Thormar K, Kjaeldgaard AL, Fabritius ML, Mondrup F, Pott FC, Moller TP, Winkel P, Wetterslev J; 6S Trial Group; Scandinavian Critical Care Trials Group. Hydroxyethyl starch 130/0.42 versus Ringer's acetate in severe sepsis. N Engl J Med. 2012 Jul 12;367(2):124-34. doi: 10.1056/NEJMoa1204242. Epub 2012 Jun 27. | |
| 27037982 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
Analysis of the primary endpoint in relation with severe renal dysfunction defined as a KDIGO (Kidney Disease Improving Global Outcomes) score ≥3 vs <3. |
| Day 4 |
| Analysis of the primary endpoint in relation with patient severity | Analysis of the primary endpoint in relation withpatient severity according to SAPS 2 (Simplified Acute Physiology Score) score: <15, 15-30, >30 | Day 4 |
| Mortality | Patient deceased: yes or no | Day 28 |
| Number of days alive without failure at Day 28 | Number of days without failure | Day 28 |
| Time to normalization of lactatemia (<2 mmol/l) | Represents time from randomization to first lactatemia <2 mmol/l in hours | Day 4 |
| Fluid balance in L | The fluid balance will be deduced from the daily weight changes in kilograms, the density of water being equal to 1 | Day 4 |
| Therapeutic adjustments including bolus vascular filling, changes in vasopressor flow, and administration of diuretics | Number of therapeutic adjustments | Day 4 |
| Length of stay in ICU (ready for discharge) | Length of stay in ICU from randomization to discharge in days | Day 28 |
| Length of stay in hospital | Number | Day 28 |
| Adverse effects | Number and type of adverse events | Day 28 |
| Background |
| Nagueh SF, Smiseth OA, Appleton CP, Byrd BF 3rd, Dokainish H, Edvardsen T, Flachskampf FA, Gillebert TC, Klein AL, Lancellotti P, Marino P, Oh JK, Popescu BA, Waggoner AD. Recommendations for the Evaluation of Left Ventricular Diastolic Function by Echocardiography: An Update from the American Society of Echocardiography and the European Association of Cardiovascular Imaging. J Am Soc Echocardiogr. 2016 Apr;29(4):277-314. doi: 10.1016/j.echo.2016.01.011. No abstract available. |
| 16984837 | Background | Volpicelli G, Mussa A, Garofalo G, Cardinale L, Casoli G, Perotto F, Fava C, Frascisco M. Bedside lung ultrasound in the assessment of alveolar-interstitial syndrome. Am J Emerg Med. 2006 Oct;24(6):689-96. doi: 10.1016/j.ajem.2006.02.013. |
| 32353418 | Background | Douglas IS, Alapat PM, Corl KA, Exline MC, Forni LG, Holder AL, Kaufman DA, Khan A, Levy MM, Martin GS, Sahatjian JA, Seeley E, Self WH, Weingarten JA, Williams M, Hansell DM. Fluid Response Evaluation in Sepsis Hypotension and Shock: A Randomized Clinical Trial. Chest. 2020 Oct;158(4):1431-1445. doi: 10.1016/j.chest.2020.04.025. Epub 2020 Apr 27. |
| 21792056 | Background | Muller L, Toumi M, Bousquet PJ, Riu-Poulenc B, Louart G, Candela D, Zoric L, Suehs C, de La Coussaye JE, Molinari N, Lefrant JY; AzuRea Group. An increase in aortic blood flow after an infusion of 100 ml colloid over 1 minute can predict fluid responsiveness: the mini-fluid challenge study. Anesthesiology. 2011 Sep;115(3):541-7. doi: 10.1097/ALN.0b013e318229a500. |
| 28640019 | Background | Biais M, de Courson H, Lanchon R, Pereira B, Bardonneau G, Griton M, Sesay M, Nouette-Gaulain K. Mini-fluid Challenge of 100 ml of Crystalloid Predicts Fluid Responsiveness in the Operating Room. Anesthesiology. 2017 Sep;127(3):450-456. doi: 10.1097/ALN.0000000000001753. |
| 19809049 | Background | Lichtenstein DA, Meziere GA, Lagoueyte JF, Biderman P, Goldstein I, Gepner A. A-lines and B-lines: lung ultrasound as a bedside tool for predicting pulmonary artery occlusion pressure in the critically ill. Chest. 2009 Oct;136(4):1014-1020. doi: 10.1378/chest.09-0001. |
| ID | Term |
|---|---|
| D012772 | Shock, Septic |
| ID | Term |
|---|---|
| D018805 | Sepsis |
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012769 | Shock |
Not provided
Not provided