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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.
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 :
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)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| low target group | Active Comparator | 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. |
|
| high target group | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| increase of mean arterial pressure at 80-85 mmHg. | Device | increase of mean arterial pressure at 80-85 mmHg (with catecholamines or volemic expansion). |
|
| Measure | Description | Time Frame |
|---|---|---|
| changes of KDIGO stage | 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) | Inclusion and day 7 |
| Measure | Description | Time Frame |
|---|---|---|
| Renal resistive index | 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 | Inclusion, and 2 hours of mean arterial pressure stabilized at 85 mmHg and every day (day 1 to day 7) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pierre ASFAR, MD PHD | University Hospital, Angers | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Angers. Médecine Intensive Réanimation et médecine hyperbare | Angers | 49100 | France |
Data will be shared upon reasonable request. Only de-identified data will be shared. Any data collected during the study may be shared. The protocol will be shared initially. Other documents may be shared at a later date upon request (e.g., the CRF to allow a collaborator to select the data they wish to access). The recipients of the data will be researchers. The data will be available for any purpose deemed relevant by the study investigator, based on a protocol provided by the requester, after verification of the obtaining of regulatory approvals, including the favorable opinion of an ethics committee.
The data will be shared after signing a negotiated data transfer agreement ( data access agreement), for the duration specified in the agreement.
The data will be made available via secure transfer (sharing platform approved by the university hospital: BlueFiles or Oodrive).
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| ID | Term |
|---|---|
| D012772 | Shock, Septic |
| ID | Term |
|---|---|
| D018805 | Sepsis |
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
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| increase of mean arterial pressure at 65-70 mmHg. | Device | increase of mean arterial pressure at 65-70 mmHg (with catecholamines or volemic expansion). |
|
| Collection of all adverse event | Difference in sides effects between target at 65-70 mmHg of MAP and 80-85 mmHg. | Day 1 to day 7 |
| 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 | Difference in need of renal replacement therapy between the group of 80-85mmHg and the groupe 65-70 mmHg, depending on the responder character | Daily to day 1 to day 7, at day 28 and day 90 |
| Number of day with supportive care in intensive care unit (renal replacement therapy, mechanical ventilation, extracorporeal membrane oxygenation) | Quantification of the number of days with supportive care (catecholamine,renal replacement therapy, mechanical ventilation, extracorporeal membrane oxygenation) | Collection daily between Day 1 and Day 7, at Day 28. |
| Number of day in intensive care unit | Quantification of the number of days hospitalized in intensive care unit | Collection at Day 28 and Day 90 |
| Number of day in hospital | Quantification of the number of days hospitalized. | Collection at Day 28 and Day 90 |
| 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 |
| Skin recoloration time evolution | measurement onto the right index finger by a standardized method after 2 hours of stabilization at 65 mmHg and after 2 hours of stabilization at 85 mmHg. | Inclusion and at 2 hours, daily between Day 1 and Day 7 |
| Skin recoloration time evolution | measurement onto the right index fingerby a standardized method depending on the randomization group. | Inclusion and at 2 hours, daily between Day 1 and Day 7 |
| D010335 |
| Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012769 | Shock |