CHU Angers. Médecine Intensive Réanimation et médecine hyperbare
Angers, 49100, France
NCT Number: NCT04281277
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.
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Not applicable
Angers, 49100, France
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)
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
increase of mean arterial pressure at 80-85 mmHg (with catecholamines or volemic expansion).
increase of mean arterial pressure at 65-70 mmHg (with catecholamines or volemic expansion).
Time frame: 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)
Time frame: 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
Time frame: Day 1 to day 7
Difference in sides effects between target at 65-70 mmHg of MAP and 80-85 mmHg.
Time frame: Inclusion, day 1 to day 7
Time frame: day 1 to day 7
Time frame: 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
Time frame: 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)
Time frame: Collection at Day 28 and Day 90
Quantification of the number of days hospitalized in intensive care unit
Time frame: Collection at Day 28 and Day 90
Quantification of the number of days hospitalized.
Time frame: Inclusion and at 2 hours, daily between Day 1 and Day 7
Time frame: Inclusion and daily between Day 1 and Day 7.
Time frame: Inclusion and daily between Day 1 and Day 7
Time frame: Daily between day 1 and day 7
Time frame: patient status (live or dead) at day 28
Time frame: patient status (live or dead) at day 90
Time frame: Inclusion and at 2 hours, daily between Day 1 and Day 7
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.
Time frame: Inclusion and at 2 hours, daily between Day 1 and Day 7
measurement onto the right index fingerby a standardized method depending on the randomization group.
University Hospital, Angers
Other Gov
Acronym: SEPSIR
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06363149
Blood Coagulation Disorders, Critical Illness
Lucknow, Uttar Pradesh, India
View Trial DetailsNCT07695337
Infections, Inflammation
Banhā, Qalyubia Governorate, Egypt
View Trial DetailsNCT05824767
Infections, Inflammation
Albuquerque, New Mexico, United States
View Trial DetailsNCT07313670
Infections, Inflammation
Karachi, Sindh, Pakistan
View Trial Details