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| ID | Type | Description | Link |
|---|---|---|---|
| No.344/KEPK/USU/2025 | Other Identifier | Health Research Ethics Committee, Universitas Sumatera Utara |
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Septic shock is a life-threatening condition that can cause severe circulatory failure and damage to vital organs, including the kidneys. One of the most serious complications of septic shock is acute kidney injury (AKI), which is associated with increased morbidity and mortality.
This study aims to evaluate the effect of early co-administration of crystalloid fluid resuscitation (30 mL/kg body weight) and norepinephrine on preventing acute kidney injury and improving hemodynamic stability in adult patients with septic shock. Patients will receive standard initial fluid resuscitation combined with early norepinephrine infusion according to a predefined clinical protocol.
Changes in blood pressure, urine output, and other hemodynamic parameters will be observed before and after the intervention. The findings of this study are expected to provide evidence to support early hemodynamic optimization strategies for reducing the risk of acute kidney injury in septic shock patients.
This study is a pretest-posttest interventional clinical study designed to evaluate the effectiveness of early co-administration of crystalloid fluid resuscitation and norepinephrine in patients with septic shock. Septic shock is characterized by persistent hypotension requiring vasopressor therapy despite adequate fluid resuscitation and is associated with a high risk of acute kidney injury.
Eligible participants are adult patients diagnosed with septic shock who meet the study inclusion criteria. All participants will receive crystalloid fluid resuscitation at a dose of 30 mL/kg body weight, followed by early initiation of norepinephrine infusion at an initial dose of approximately 0.05 µg/kg/min, titrated according to hemodynamic response and clinical judgment.
Hemodynamic parameters, including mean arterial pressure, heart rate, oxygen saturation, urine output, and central venous pressure (when available), will be measured before and after the intervention. Renal function indicators will be monitored to assess the occurrence of early acute kidney injury.
The primary objective of this study is to evaluate the effect of early combined fluid resuscitation and norepinephrine administration on the prevention of acute kidney injury. Secondary objectives include assessment of changes in hemodynamic stability following the intervention. The results of this study are expected to contribute to evidence-based management strategies for septic shock in resource-limited clinical settings.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Early Fluid Resuscitation Plus Norepinephrine | Experimental | Participants in this single study arm receive early crystalloid fluid resuscitation at a dose of 30 mL/kg body weight combined with early initiation of norepinephrine infusion. Norepinephrine is started at an initial dose of approximately 0.05 µg/kg/min and titrated according to hemodynamic response to achieve adequate mean arterial pressure. Hemodynamic and renal parameters are assessed before and after the intervention. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Norepinephrine | Drug | Norepinephrine is administered as an intravenous infusion initiated early in patients with septic shock at an initial dose of approximately 0.05 µg/kg/min. The dose is titrated based on hemodynamic response to achieve and maintain adequate mean arterial pressure in accordance with standard clinical practice. |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of Acute Kidney Injury | Acute kidney injury is assessed based on changes in renal function parameters following early co-administration of crystalloid fluid resuscitation and norepinephrine in patients with septic shock. | Within 48 hours after intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Mean Arterial Pressure | Change in mean arterial pressure measured before and after administration of crystalloid fluid and norepinephrine. | Within 30 minutes after intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Irfan Julio Nasution, MD | Contact | +6285296993309 | irfanjulionst@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Irfan Julio Nasution, MD | Universitas Sumatera Utara | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35806919 | Background | Mehta Y, Paul R, Rabbani R, Acharya SP, Withanaarachchi UK. Sepsis Management in Southeast Asia: A Review and Clinical Experience. J Clin Med. 2022 Jun 23;11(13):3635. doi: 10.3390/jcm11133635. | |
| 37608327 | Background | Monnet X, Lai C, Ospina-Tascon G, De Backer D. Evidence for a personalized early start of norepinephrine in septic shock. Crit Care. 2023 Aug 22;27(1):322. doi: 10.1186/s13054-023-04593-5. |
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| ID | Term |
|---|---|
| D012772 | Shock, Septic |
| D058186 | Acute Kidney Injury |
| D018805 | Sepsis |
| ID | Term |
|---|---|
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D009638 | Norepinephrine |
| ID | Term |
|---|---|
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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This study uses a single-group pretest-posttest design in which all participants receive early co-administration of crystalloid fluid resuscitation and norepinephrine. Hemodynamic and renal parameters are assessed before and after the intervention.
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| Crystalloid Fluid Resuscitation | Other | Participants receive intravenous crystalloid fluid resuscitation at a total dose of 30 mL per kilogram of body weight as part of early management of septic shock. Fluid administration is provided according to institutional protocols and patient clinical condition. |
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| 32059682 | Background | Ospina-Tascon GA, Hernandez G, Alvarez I, Calderon-Tapia LE, Manzano-Nunez R, Sanchez-Ortiz AI, Quinones E, Ruiz-Yucuma JE, Aldana JL, Teboul JL, Cavalcanti AB, De Backer D, Bakker J. Effects of very early start of norepinephrine in patients with septic shock: a propensity score-based analysis. Crit Care. 2020 Feb 14;24(1):52. doi: 10.1186/s13054-020-2756-3. |
| 30704260 | Background | Permpikul C, Tongyoo S, Viarasilpa T, Trainarongsakul T, Chakorn T, Udompanturak S. Early Use of Norepinephrine in Septic Shock Resuscitation (CENSER). A Randomized Trial. Am J Respir Crit Care Med. 2019 May 1;199(9):1097-1105. doi: 10.1164/rccm.201806-1034OC. |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D012769 | Shock |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D000588 |
| Amines |
| D015306 | Biogenic Monoamines |
| D001679 | Biogenic Amines |
| D002395 | Catecholamines |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |