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The Effect of Albumin Supplementation on the Inflammatory and Oxidative Stress Markers in Septic Patients
There is currently no uniform target for serum albumin levels in some pathological conditions, but recent studies have shown that serum albumin concentrations, disease severity, and mortality rates have been linked. Although the exact mechanism is unclear, serum albumin levels may have a protective effect on the potential antioxidant effect of maintaining physiological homeostasis and its anti-inflammatory effects. The indication and efficacy of parenteral albumin therapy in the care of patients in critical condition has long been a hot topic. Although previous mortality endpoint studies were negative, it is not certain that they can be used clearly in intensive care. According to earlier research, albumin is a very important circulating antioxidant. It is believed that early suplementattion of albumin may have a beneficial effect on oxidative stress and inflammation in septic patients.
The aim of our study is to investigate changes in parameters (inflammation, oxidative stress) that can be directly influenced by the administration of albumin in septic cases in need of intensive care. Also in our earlier, relatively small number of studies, chemiluminescence analysis of non-enzymatic total antioxidant capacity showed an increase in total antioxidant capacity in septic patients. The proposed study may also clarify the background of pathophysiological changes behind this phenomenon.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Albumin Supplementation Albumin Therapy Sepsis | Drug: Human albumin | Early Phase 1 |
There is currently no uniform target for serum albumin levels in some pathological conditions, but recent studies have shown that serum albumin concentrations, disease severity, and mortality rates have been linked. Although the exact mechanism is unclear, serum albumin levels may have a protective effect on the potential antioxidant effect of maintaining physiological homeostasis and its anti-inflammatory effects. The indication and efficacy of parenteral albumin therapy in the care of patients in critical condition has long been a hot topic. Although previous mortality endpoint studies were negative, it is not certain that they can be used clearly in intensive care. According to earlier research, albumin is a very important circulating antioxidant. It is believed that early suplementattion of albumin may have a beneficial effect on oxidative stress and inflammation in septic patients.
The aim of our study is to investigate changes in parameters (inflammation, oxidative stress) that can be directly influenced by the administration of albumin in septic cases in need of intensive care. Also in our earlier, relatively small number of studies, chemiluminescence analysis of non-enzymatic total antioxidant capacity showed an increase in total antioxidant capacity in septic patients. The proposed study may also clarify the background of pathophysiological changes behind this phenomenon.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 30 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | The Effect of Albumin Supplementation on the Inflammatory and Oxidative Stress Markers in Septic Patients |
| Actual Study Start Date : | April 1, 2019 |
| Estimated Primary Completion Date : | April 1, 2021 |
| Estimated Study Completion Date : | April 1, 2022 |
| Arm | Intervention/treatment |
|---|---|
|
Active Comparator: Septic patients receiving albumin replacement
Septic patients receiving albumin replacement 20 ml Inj Human Albumin 20% -3x100 ml- 3 day
|
Drug: Human albumin
Patients are divided into 2 groups by envelope randomization. In the treated group, albumin supplementation occurs up to a target of 30 g / l at the end of the test period at a maximum dose of 3 x 100 ml, and no albumin is added above the control value of 20 g / l. Patients with albumin below 20 g / l in the control group are excluded from the study and albumin supplemented. Blood samples are taken directly at the intensive care class, and at the same time on the following days. Urine was collected for 24 hours. The kinetics of the parameters are examined for five days.
|
| No Intervention: Septic patients not receiving albumin replacement |
- The effect of albumin supplementation on PCT level [ Time Frame: 24 months ]The effect of albumin supplementation on the inflammatory and oxidative stress marker PCT will be assesed
- The effect of albumin supplementation on CRP level [ Time Frame: 24 months ]The effect of albumin supplementation on the inflammatory and oxidative stress marker CRP will be assesed
- The effect of albumin supplementation on serum- total protein concentration [ Time Frame: 24 months ]The effect of albumin supplementation on the inflammatory and oxidative stress markers total protein will be assesed
- The effect of albumin supplementation on albumin concentration [ Time Frame: 24 months ]The effect of albumin supplementation on the inflammatory and oxidative stress marker albumin will be assesed
| Ages Eligible for Study: | 18 Years to 99 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Primarily, patients with sepsis or septic shock are enrolled into patients who are admitted to an intensive care class or who become septic in the intensive care unit (based on the sepsis definition).
Exclusion Criteria:
- Under 18 years old
- documented treatment or co-morbidity affecting the immune response: malignant hematological disease
- chronic steroid use,
- biological therapy,
- taking immunosuppressive drugs after organ transplantation,
- end stage tumor disease.
| Contact: Csaba Csontos, PhD | 003672536000 /32428 | csaba.csontos@gmail.com |
| Hungary | |
| University of Pécs Department of Anaesthesiology and Intensive Therapy | Recruiting |
| Pécs, Ifjúság Str 13., Hungary, 7524 | |
| Contact: Csaba Csontos, PhD 003672536000/ 32428 | |
| Universitty of Pecs Department of Anaesthesiology and Intensive Therapy | Recruiting |
| Pécs, Ifjúság Str.13., Hungary, 7624 | |
| Tracking Information | |||||||
|---|---|---|---|---|---|---|---|
| First Submitted Date ICMJE | April 16, 2019 | ||||||
| First Posted Date ICMJE | May 15, 2019 | ||||||
| Last Update Posted Date | May 15, 2019 | ||||||
| Actual Study Start Date ICMJE | April 1, 2019 | ||||||
| Estimated Primary Completion Date | April 1, 2021 (Final data collection date for primary outcome measure) | ||||||
| Current Primary Outcome Measures ICMJE |
|
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||
| Change History | No Changes Posted | ||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||
| Descriptive Information | |||||||
| Brief Title ICMJE | The Effect of Albumin Supplementation on the Inflammatory and Oxidative Stress Markers in Septic Patients | ||||||
| Official Title ICMJE | The Effect of Albumin Supplementation on the Inflammatory and Oxidative Stress Markers in Septic Patients | ||||||
| Brief Summary |
There is currently no uniform target for serum albumin levels in some pathological conditions, but recent studies have shown that serum albumin concentrations, disease severity, and mortality rates have been linked. Although the exact mechanism is unclear, serum albumin levels may have a protective effect on the potential antioxidant effect of maintaining physiological homeostasis and its anti-inflammatory effects. The indication and efficacy of parenteral albumin therapy in the care of patients in critical condition has long been a hot topic. Although previous mortality endpoint studies were negative, it is not certain that they can be used clearly in intensive care. According to earlier research, albumin is a very important circulating antioxidant. It is believed that early suplementattion of albumin may have a beneficial effect on oxidative stress and inflammation in septic patients. The aim of our study is to investigate changes in parameters (inflammation, oxidative stress) that can be directly influenced by the administration of albumin in septic cases in need of intensive care. Also in our earlier, relatively small number of studies, chemiluminescence analysis of non-enzymatic total antioxidant capacity showed an increase in total antioxidant capacity in septic patients. The proposed study may also clarify the background of pathophysiological changes behind this phenomenon. |
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| Detailed Description |
There is currently no uniform target for serum albumin levels in some pathological conditions, but recent studies have shown that serum albumin concentrations, disease severity, and mortality rates have been linked. Although the exact mechanism is unclear, serum albumin levels may have a protective effect on the potential antioxidant effect of maintaining physiological homeostasis and its anti-inflammatory effects. The indication and efficacy of parenteral albumin therapy in the care of patients in critical condition has long been a hot topic. Although previous mortality endpoint studies were negative, it is not certain that they can be used clearly in intensive care. According to earlier research, albumin is a very important circulating antioxidant. It is believed that early suplementattion of albumin may have a beneficial effect on oxidative stress and inflammation in septic patients. The aim of our study is to investigate changes in parameters (inflammation, oxidative stress) that can be directly influenced by the administration of albumin in septic cases in need of intensive care. Also in our earlier, relatively small number of studies, chemiluminescence analysis of non-enzymatic total antioxidant capacity showed an increase in total antioxidant capacity in septic patients. The proposed study may also clarify the background of pathophysiological changes behind this phenomenon. |
||||||
| Study Type ICMJE | Interventional | ||||||
| Study Phase ICMJE | Early Phase 1 | ||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Triple (Participant, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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| Condition ICMJE |
|
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| Intervention ICMJE | Drug: Human albumin
Patients are divided into 2 groups by envelope randomization. In the treated group, albumin supplementation occurs up to a target of 30 g / l at the end of the test period at a maximum dose of 3 x 100 ml, and no albumin is added above the control value of 20 g / l. Patients with albumin below 20 g / l in the control group are excluded from the study and albumin supplemented. Blood samples are taken directly at the intensive care class, and at the same time on the following days. Urine was collected for 24 hours. The kinetics of the parameters are examined for five days.
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||
| Recruitment Status ICMJE | Recruiting | ||||||
| Estimated Enrollment ICMJE |
30 | ||||||
| Original Estimated Enrollment ICMJE | Same as current | ||||||
| Estimated Study Completion Date ICMJE | April 1, 2022 | ||||||
| Estimated Primary Completion Date | April 1, 2021 (Final data collection date for primary outcome measure) | ||||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
|
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years to 99 Years (Adult, Older Adult) | ||||||
| Accepts Healthy Volunteers ICMJE | No | ||||||
| Contacts ICMJE |
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| Listed Location Countries ICMJE | Hungary | ||||||
| Removed Location Countries | |||||||
| Administrative Information | |||||||
| NCT Number ICMJE | NCT03950778 | ||||||
| Other Study ID Numbers ICMJE | Upecs-UP-MS-ICU-Albumin | ||||||
| Has Data Monitoring Committee | Yes | ||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | University of Pecs | ||||||
| Study Sponsor ICMJE | University of Pecs | ||||||
| Collaborators ICMJE | Not Provided | ||||||
| Investigators ICMJE | Not Provided | ||||||
| PRS Account | University of Pecs | ||||||
| Verification Date | May 2019 | ||||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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