CRRT Timing in Sepsis-associated AKI in ICU

Not Applicable

• Conditions: Sepsis-Associated Organ Dysfunction; RTT
• Interventions: Procedure: continuous renal replacement therapies

• Registration Number: NCT03175328
• Lead Sponsor: Second Affiliated Hospital of Guangzhou Medical University

Brief Summary

Sepsis continues to be a major global cause of both mortality and morbidity. Furthermore, the development of acute kidney injury (AKI) in sepsis increases the risk of unfavorable outcomes. Besides source control, fluid resuscitation and the use of antibiotics, application of extracorporeal renal replacement therapies (RRT) is the predominant treatment for sepsis-associated AKI (SAKI). However, the timing of initiation of RRT remains controversial. It is reported that a correlation was observed between the concentrations of circulating inflammatory cytokines and mortality in patients with septic shock. Therefore, it is hypothesis that adequate removal of inflammatory mediators from the circulation may provide a potential therapy for this devastating condition. Indeed, data from meta-analyses, observational studies and randomized controlled trial (RCT) suggests that initiating RRT in critical ill patients (including patients with sepsis and non-sepsis) at early stage may be beneficial. But in some studies, initiating RRT at early stage do not shown to improve survival compared with initiating RRT at late stage. At present, large-scale prospective RCT about the timing for initiating RRT in SAKI was still lack.The decision when to start RRT is not merely academic but may impact on outcomes. Therefore, in our study, 460 patients with SAKI at KDIGO 2 from multicenter in China will be recruited. And then the patients will be divided into early group and delayed group randomly. In the early group, continuous RRT (CRRT) was started immediately after randomization. In the delay group, CRRT was initiated if at least one of the following criteria was met: KDIGO 3, severe hyperkalemia, pulmonary edema, blood urea nitrogen level higher than 112 mg per deciliter after randomization. Overall survival at day 90 will be observed in order to understand whether different CRRT strategy would affect the outcomes of SAKI. This clinical study will be a large-scale, multi center, prospective, randomized trial about SAKI. It will help clinician choose appropriate timing to initiate CRRT and improve outcomes of SAKI.

Detailed Description

In our study, 460 patients with SAKI at KDIGO 2 from multicenter in China will be recruited. And then the patients will be divided into early group and delayed group randomly. In the early group, CRRT was started immediately after randomization. In the delay group, CRRT was initiated if at least one of the following criteria was met: KDIGO 3, severe hyperkalemia, pulmonary edema, blood urea nitrogen level higher than 112 mg per deciliter after randomization. Overall survival at day 90 will be observed in order to understand whether different CRRT strategy would affect the outcomes of SAKI.

Study Timeline

• Study First Submitted: 2017-06-01
• Study First Submitted QC: 2017-06-01
• Study First Posted: 2017-06-05
• Study Start: 2019-08-22
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-21
• Last Update Posted: 2021-12-22
• Primary Completion: 2023-08-21
• Study Completion: 2024-08-21

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 460

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
early group	continuous renal replacement therapies	In the early group, continuous renal replacement therapies was started within 8 hours after randomization.
delayed group	continuous renal replacement therapies	In the delayed group, continuous renal replacement therapies was initiated if at least one of the following criteria was met: KDIGO 3, severe hyperkalemia, pulmonary edema, blood urea nitrogen level higher than 112 mg per deciliter after randomization.

Primary Outcome Measures

Name	Time	Method
overall mortality	90 days	overall survival measured from randomization to death or day 90

Secondary Outcome Measures

Name	Time	Method
the number of days alive without CRRT, mechanical ventilation and vasopressor	90 days	the numbers of CRRT-free days, mechanical ventilation-free days and vasopressor-free days, between D0 and up to D90
organ dysfunction	90 days	the frequency of occurrence at least one organ dysfunction besides the kidney
recovery rate of renal function	90 days	the recovery rate of renal function will be compared between groups
length of ICU stay and in-hospital stay	90 days	average length of ICU stay and in-hospital stay will be compared
the percentage of receipt of CRRT at least once in the delayed group	90 days	the percentage of receipt of CRRT at least once in the delayed group
difference of the Sequential Organ Failure Assessment score	28 days	difference of the Sequential Organ Failure Assessment (SOFA) score (0\~24) at day 0, 1, 3, 7, 14 and day 28 between groups. Higher score means more illness.
the rate of complications potentially related to CRRT	90 days	the rate of complications potentially related to CRRT

Trial Locations

Locations (1)

the Second Affiliated Hospital of Guangzhou Medical University; 🇨🇳 Guangzhou, Guangdong, China