Sepsis-Associated Organ DysfunctionCRTSAKINCT03175328
CRRT Timing in Sepsis-associated AKI in ICU
A study testing continuous renal replacement therapies in people with Sepsis-Associated Organ Dysfunction and RTT, run by Second Affiliated Hospital of Guangzhou Medical University at 2 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Sepsis-Associated Organ Dysfunction, RTT
- What is being tested?
- continuous renal replacement therapies
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 460 participants
- Where
- 2 sitesChina
- Study dates
- 22 Aug 2019to 21 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
the Second Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 510260
Shi-kun Qian, MD, 86 20 81340031
- Recruiting
the Second Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 510260
Xu-ming Xiong, PHD, +86 18926298697, xiongxuming9@126.com
Wei-yan Chen, MD, +86 13751845652, sam11124@163.com
About this study
Official title: The Timing of Continuous Renal Replacement Therapy Initiation in Sepsis-associated Acute Kidney Injury in the Intensive Care Unit
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.
Read the 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.
- Conditions
- Sepsis-Associated Organ Dysfunction, RTT
- Being tested
- continuous renal replacement therapies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
continuous renal replacement therapiesProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| early group | Experimental | In the early group, continuous renal replacement therapies was started within 8 hours after randomization. Receives: Procedure: continuous renal replacement therapies |
| delayed group | Experimental | 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. Receives: Procedure: continuous renal replacement therapies |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall mortality
overall survival measured from randomization to death or day 90
Measured: 90 days
Secondary outcomes (7)
recovery rate of renal function
the recovery rate of renal function will be compared between groups
Measured: 90 days
organ dysfunction
the frequency of occurrence at least one organ dysfunction besides the kidney
Measured: 90 days
length of ICU stay and in-hospital stay
average length of ICU stay and in-hospital stay will be compared
Measured: 90 days
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
Measured: 90 days
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
Measured: 90 days
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.
Measured: 28 days
the rate of complications potentially related to CRRT
the rate of complications potentially related to CRRT
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2017
- Study start22 Aug 2019
- Primary completion21 Aug 2023 (estimated)
- Study completion21 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Sepsis-Associated Organ DysfunctionStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital of Guangzhou Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 460 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xu-ming Xiong, PHD, Study director, Second Affiliated Hospital of Guangzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03175328
- Sponsor's protocol ID
- ICU-01
- Acronym
- CRTSAKI
- Status last verified
- Dec 2021
- First submitted
- 1 Jun 2017
- Last updated
- 22 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fayad AI, Buamscha DG, Ciapponi A. Timing of kidney replacement therapy initiation for acute kidney injury. Cochrane Database Syst Rev. 2022 Nov 23;11(11):CD010612. doi: 10.1002/14651858.CD010612.pub3.
PubMed 36416787Chen 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.
PubMed 33608398
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Timing of Continuous Renal Replacement Therapy Initiation in Sepsis-associated Acute Kidney Injury in the Intensive Care Unit
- ClinicalTrials.gov ID
- NCT03175328
- Acronym / sponsor ID
- CRTSAKI / ICU-01
- Conditions
- Sepsis-Associated Organ Dysfunction, RTT
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 460 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital of Guangzhou Medical UniversityUniversity, hospital or other
- Study start
- 22 Aug 2019 (actual)
- Primary completion
- 21 Aug 2023 (estimated)
- Study completion
- 21 Aug 2024 (estimated)
- First posted
- 5 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| early group | Experimental | Procedure: continuous renal replacement therapiesIn the early group, continuous renal replacement therapies was started within 8 hours after randomization. |
| delayed group | Experimental | Procedure: continuous renal replacement therapiesIn 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. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| continuous renal replacement therapiesThe 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. | Procedure or surgery | delayed group, early group |
Primary outcome
overall mortality
Time frame: 90 days
overall survival measured from randomization to death or day 90
7 secondary outcomes
recovery rate of renal function
Time frame: 90 days
organ dysfunction
Time frame: 90 days
length of ICU stay and in-hospital stay
Time frame: 90 days
the percentage of receipt of CRRT at least once in the delayed group
Time frame: 90 days
the number of days alive without CRRT, mechanical ventilation and vasopressor
Time frame: 90 days
difference of the Sequential Organ Failure Assessment score
Time frame: 28 days
the rate of complications potentially related to CRRT
Time frame: 90 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2021.
- Derived from this study: PubMed 36416787Fayad AI, Buamscha DG, Ciapponi A. Timing of kidney replacement therapy initiation for acute kidney injury. Cochrane Database Syst Rev. 2022 Nov 23;11(11):CD010612. doi: 10.1002/14651858.CD010612.pub3.
- Derived from this study: PubMed 33608398Chen 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xu-ming Xiong, PHD study director
Second Affiliated Hospital of Guangzhou Medical University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing continuous renal replacement therapies in people with Sepsis-Associated Organ Dysfunction and RTT, run by Second Affiliated Hospital of Guangzhou Medical University at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xu-ming Xiong (+86 20 34152225, xiongxuming9@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
overall mortality (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03175328, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2021.