SEPSIR: Relation Between Mean Arterial Pressure and Renal Resistive Index in the Early Phase of Septic Shock
Study Details
Study Description
Brief Summary
This study evaluates if improvement of renal resistive index when mean arterial pressure increase (at 65 mmHg to 85 mmHg) in early phase of septic shock is predictive of better renal survival.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
Learned societes (survival sepsis campaign and ESICM) are currently recommending a mean arterial pressure (MAP) target at 65 mmHg in septic shoc with a potential increase to 85 mmHg in patients with medical history of arterial hypertension.
A high renal resistive index on the first day of septic shock was associated with acute renal failure more frequently on the 5th day. A decrease in the renal resistance index was also objectified during the increase in MAP.
The main objective of this trial is to study the relationship between the improvement of the resistance index during a test of increase in average blood pressure during septic shock and the improvement of renal function
In this interventional monocenter trial, we will measure the renal resistive index after stabilization of the MAP at 65 mmHg for two hours, then after 2 hours of stabilization at 85 mmHg. This part allows us to define the patients "responding" to the renal resistive index (improvement of the resitive renal index when the MAP increases).
Then, patients will be randomized into two groups :
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first group with a MAP target at 65 mmHg
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second group with a MAP target at 85 mmHg. There will be a stratification on the responder character to the renal resistance index.
Finally, we will assess renal function on the 7th day (with the assessment of serum creatinine and the change of stage of the KDIGO classification)
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: low target group target of mean arterial pressure(MAP) at 65-70 mmHg. The therapeutic means used to obtain the MAP objectives within each group (increase in catecholamines and / or volume expansion) are left to the discretion of the clinician, in accordance with the recommendations. |
Device: increase of mean arterial pressure at 65-70 mmHg.
increase of mean arterial pressure at 65-70 mmHg (with catecholamines or volemic expansion).
|
| Experimental: high target group target of mean arterial pressure (MAP) at 80-85 mmHg. The therapeutic means used to obtain the MAP objectives within each group (increase in catecholamines and / or volume expansion) are left to the discretion of the clinician, in accordance with the recommendations. |
Device: increase of mean arterial pressure at 80-85 mmHg.
increase of mean arterial pressure at 80-85 mmHg (with catecholamines or volemic expansion).
|
Outcome Measures
Primary Outcome Measures
- changes of KDIGO stage [Inclusion and day 7]
modification of the KDIGO classification stage (estimated based on serum creatinine and diuresis) between the group with low target of mean arterial pressure ( 65-70 mmHg) and high target MAP (80-85 mmHg)
Secondary Outcome Measures
- Renal resistive index [Inclusion, and 2 hours of mean arterial pressure stabilized at 85 mmHg and every day (day 1 to day 7)]
We will assess the evolution of the renal resistive index during an increase in the target of MAP in the early phase of septic shock . We will assess the evolution of renal resistive index according to the comorbidities, as a function of time in septic shock, according to the hemodynamic data, according to quantity of filling solution administered and catecholamine doses
- Pulse wave speed indexed to size measure by popmetre (unit = m/s) [Inclusion and 2 hours of mean arterial pressure stabilized at 85 mmH, and every day (day 1 to day 7)]
We will assess the correlation between variation in resistive renal index and arterial stifness (represented by the speed of the index- finger pulse wave measured by pOpmetre)
- Transit time measure by popmetre (unit = second ) [Inclusion and 2 hours of mean arterial pressure stabilized at 85 mmH, and every day (day 1 to day 7)]
We will assess the correlation between variation in resistive renal index and arterial stifness (represented by the speed of the index- finger pulse wave measured by pOpmetre)
- Collection of all adverse event [Day 1 to day 7]
Difference in sides effects between target at 65-70 mmHg of MAP and 80-85 mmHg.
- amount of fluids (unit = L or L/day) [Inclusion, day 1 to day 7]
- catecholamines free days [day 1 to day 7]
- extra renal replacement free days [Daily to day 1 to day 7, at day 28 and day 90]
Difference in need of renal replacement therapy between the group of 80-85mmHg and the groupe 65-70 mmHg, depending on the responder character
- Number of day with supportive care in intensive care unit (renal replacement therapy, mechanical ventilation, extracorporeal membrane oxygenation) [Collection daily between Day 1 and Day 7, at Day 28.]
Quantification of the number of days with supportive care (catecholamine,renal replacement therapy, mechanical ventilation, extracorporeal membrane oxygenation)
- Number of day in intensive care unit [Collection at Day 28 and Day 90]
Quantification of the number of days hospitalized in intensive care unit
- Number of day in hospital [Collection at Day 28 and Day 90]
Quantification of the number of days hospitalized.
- hemodynamic data collected by swan ganz or PICCO catheter [Inclusion and at 2 hours, daily between Day 1 and Day 7]
- quantity of nephrotoxic drugs [Inclusion and daily between Day 1 and Day 7.]
- serum creatinine (unit = µmol/L) [Inclusion and daily between Day 1 and Day 7]
- Diuresis (unit = mL per day) [Daily between day 1 and day 7]
- Survival at day 28 [patient status (live or dead) at day 28]
- Survival at day 90 [patient status (live or dead) at day 90]
Eligibility Criteria
Criteria
Inclusion Criteria:
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adult patients (≥ 18 ans)
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Admitted to the intensive care unit of Angers with
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arterial hypotension requiring the etablishment of catecholamines
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In a context of proven or suspected sepsis, whaterver the cause of this infection.
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norepinephrine dose ⩾ 0.1µg/kg/min
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After 2 hours of stabilization at 65 mmHg of mean arterial pressure
Exclusion Criteria:
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Pre-existing chronic renal failure (glomerular filtration rate < 60 mL/min with MDRD)
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Solitary kidney (anatomical or functional)
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History of united or bilateral stenosis of the renal arteries
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decision to stop or limit treatment
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patient with an emergency indication of renal replacement therapy (severe hyperkalemia, severe metabolical acidosis with pH <7.15, acute pulmonary edema due to fluid overload resulting in severe hypoxemia, serum urea concentration > 40 mmol/l and oliguria/anuria > 72 h.)
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pregnant, lactating or parturient woman
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patient deprived of liberty by judicial or administrative decision
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patient with psychiatric compulsory care
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patient subject to legal protection measures
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | CHU Angers. Médecine Intensive Réanimation et médecine hyperbare | Angers | France | 49100 |
Sponsors and Collaborators
- University Hospital, Angers
Investigators
- Principal Investigator: Pierre ASFAR, MD PHD, University Hospital, Angers
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 49RC19_0236