CRRT Timing in Sepsis-associated AKI in ICU (CRTSAKI)
Primary Purpose
Sepsis-Associated Organ Dysfunction, RTT
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
continuous renal replacement therapies
Sponsored by
About this trial
This is an interventional treatment trial for Sepsis-Associated Organ Dysfunction
Eligibility Criteria
Inclusion criteria
- Age between 18 and 90 years.
- Patients admitted into ICU with Sepsis (sepsis-3) compatible with the diagnosis of AKI at stage 2 of KDIGO classification.
- Informed consent provided by the patient or person with decisional responsibility.
Exclusion criteria
1. Presence of one of the emergent CRRT conditions before randomization:
- Hyperkalemia > 6.0 mmol/L or > 5.5 mmol/L persisting despite medical treatment.
- Acute pulmonary edema due to fluid overload responsible for severe hypoxemia requiring oxygen flow rate > 5 L/min to maintain a percutaneous oxygen saturation (SpO2) > 95% or a fraction of inspiration oxygen (FiO2) > 50% in patients already on invasive or non-invasive mechanical ventilation and despite diuretic therapy.
- Blood urea nitrogen (BUN) > 112 mg/dl (40 mmol/L). 2. Pre-existing severe chronic renal failure [estimated glomerular filtration rate (eGFR) < 30 ml/min].
3. Previous renal replacement therapy. 4. Prior kidney t
Sites / Locations
- the Second Affiliated Hospital of Guangzhou Medical UniversityRecruiting
- the Second Affiliated Hospital of Guangzhou Medical UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
early group
delayed group
Arm Description
In the early group, continuous renal replacement therapies was started within 8 hours after randomization.
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.
Outcomes
Primary Outcome Measures
overall mortality
overall survival measured from randomization to death or day 90
Secondary Outcome Measures
recovery rate of renal function
the recovery rate of renal function will be compared between groups
organ dysfunction
the frequency of occurrence at least one organ dysfunction besides the kidney
length of ICU stay and in-hospital stay
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
the percentage of receipt of CRRT at least once in the delayed group
the number of days alive without CRRT, mechanical ventilation and vasopressor
the numbers of CRRT-free days, mechanical ventilation-free days and vasopressor-free days, between D0 and up to D90
difference of the Sequential Organ Failure Assessment score
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
the rate of complications potentially related to CRRT
Full Information
NCT ID
NCT03175328
First Posted
June 1, 2017
Last Updated
December 21, 2021
Sponsor
Second Affiliated Hospital of Guangzhou Medical University
1. Study Identification
Unique Protocol Identification Number
NCT03175328
Brief Title
CRRT Timing in Sepsis-associated AKI in ICU
Acronym
CRTSAKI
Official Title
The Timing of Continuous Renal Replacement Therapy Initiation in Sepsis-associated Acute Kidney Injury in the Intensive Care Unit
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Recruiting
Study Start Date
August 22, 2019 (Actual)
Primary Completion Date
August 21, 2023 (Anticipated)
Study Completion Date
August 21, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Second Affiliated Hospital of Guangzhou Medical University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sepsis-Associated Organ Dysfunction, RTT
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
460 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
early group
Arm Type
Experimental
Arm Description
In the early group, continuous renal replacement therapies was started within 8 hours after randomization.
Arm Title
delayed group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
continuous renal replacement therapies
Intervention Description
The choice of the method of continuous renal replacement therapy (device setting and anticoagulation method) is left to the discretion of each study site and was prescribed and monitored according to national guidelines.
Primary Outcome Measure Information:
Title
overall mortality
Description
overall survival measured from randomization to death or day 90
Time Frame
90 days
Secondary Outcome Measure Information:
Title
recovery rate of renal function
Description
the recovery rate of renal function will be compared between groups
Time Frame
90 days
Title
organ dysfunction
Description
the frequency of occurrence at least one organ dysfunction besides the kidney
Time Frame
90 days
Title
length of ICU stay and in-hospital stay
Description
average length of ICU stay and in-hospital stay will be compared
Time Frame
90 days
Title
the percentage of receipt of CRRT at least once in the delayed group
Description
the percentage of receipt of CRRT at least once in the delayed group
Time Frame
90 days
Title
the number of days alive without CRRT, mechanical ventilation and vasopressor
Description
the numbers of CRRT-free days, mechanical ventilation-free days and vasopressor-free days, between D0 and up to D90
Time Frame
90 days
Title
difference of the Sequential Organ Failure Assessment score
Description
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.
Time Frame
28 days
Title
the rate of complications potentially related to CRRT
Description
the rate of complications potentially related to CRRT
Time Frame
90 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria
Age between 18 and 90 years.
Patients admitted into ICU with Sepsis (sepsis-3) compatible with the diagnosis of AKI at stage 2 of KDIGO classification.
Informed consent provided by the patient or person with decisional responsibility.
Exclusion criteria
1. Presence of one of the emergent CRRT conditions before randomization:
Hyperkalemia > 6.0 mmol/L or > 5.5 mmol/L persisting despite medical treatment.
Acute pulmonary edema due to fluid overload responsible for severe hypoxemia requiring oxygen flow rate > 5 L/min to maintain a percutaneous oxygen saturation (SpO2) > 95% or a fraction of inspiration oxygen (FiO2) > 50% in patients already on invasive or non-invasive mechanical ventilation and despite diuretic therapy.
Blood urea nitrogen (BUN) > 112 mg/dl (40 mmol/L). 2. Pre-existing severe chronic renal failure [estimated glomerular filtration rate (eGFR) < 30 ml/min].
3. Previous renal replacement therapy. 4. Prior kidney t
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xu-ming Xiong
Phone
+86 20 34152225
Email
xiongxuming9@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Wei-yan Chen, MD
Phone
+86 20 34153246
Email
sam11124@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xu-ming Xiong, PHD
Organizational Affiliation
Second Affiliated Hospital of Guangzhou Medical University
Official's Role
Study Director
Facility Information:
Facility Name
the Second Affiliated Hospital of Guangzhou Medical University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510260
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shi-kun Qian, MD
Phone
86 20 81340031
Facility Name
the Second Affiliated Hospital of Guangzhou Medical University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510260
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xu-ming Xiong, PHD
Phone
+86 18926298697
Email
xiongxuming9@126.com
First Name & Middle Initial & Last Name & Degree
Wei-yan Chen, MD
Phone
+86 13751845652
Email
sam11124@163.com
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
33608398
Citation
Chen WY, Cai LH, Zhang ZH, Tao LL, Wen YC, Li ZB, Li L, Ling Y, Li JW, Xing R, Liu XY, Lin ZD, Deng ZT, Wang SH, Lin QH, Zhou DR, He ZJ, Xiong XM. The timing of continuous renal replacement therapy initiation in sepsis-associated acute kidney injury in the intensive care unit: the CRTSAKI Study (Continuous RRT Timing in Sepsis-associated AKI in ICU): study protocol for a multicentre, randomised controlled trial. BMJ Open. 2021 Feb 19;11(2):e040718. doi: 10.1136/bmjopen-2020-040718.
Results Reference
derived
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CRRT Timing in Sepsis-associated AKI in ICU
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