- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06612073
Evaluation Of The Degree Of Kidney Injury in Children With Hypovolemic Shock
To evaluate renal affection and its degree in hypovolemic shocked
children
Study Overview
Status
Detailed Description
Acute kidney injury is a syndrome characterised by the rapid loss of the kidney's excretory function and is typically diagnosed by the accumulation of end products of nitrogen metabolism (urea and creatinine) or decreased urine output, or both. It is the clinical manifestation of several disorders that affect the kidney acutely. Acute kidney injury is common in hospital patients and very common in critically ill patients. In these patients, it is most often secondary to extrarenal events.. In low-income and middle-income countries, infections and hypovolaemic shock are the predominant causes of AKI. In high-income countries, AKI mostly occurs in elderly patients who are in hospital, and is related to sepsis, drugs or invasive procedures. Infection and trauma-related AKI and AKD are frequent in all regions.
There are numerous potential causes of AKI, mainly related to a focal mismatch between oxygen and nutrient delivery (because of impaired microcirculation) to the nephrons and increased energy demands (due to cellular stress).
The prerenal form of AKI is due to any cause of reduced blood flow to the kidney. This may be part of systemic hypoperfusion resulting from hypovolemia or due to selective hypoperfusion of the kidneys, such as
- Hypovolemia: hemorrhage, severe burns, and gastrointestinal fluid losses such as diarrhea, vomiting, and high ostomy output.
- Hypotension from systemic vasodilation: septic shock, anaphylaxis, anesthesia administration.
- Glomerular efferent arteriolar vasodilation (causing intraglomerular hypotension): ACE inhibitors, angiotensin receptor blockers.
Diagnosis
• Increase in serum creatinine by 0.3 mg/dL or more (26.5 μmol/L or more) within 48 hours And other diagnostic criteria according to the stage Shock is the state of insufficient blood flow to the tissues of the body as a result of problems with the circulatory system.[5][6]Initial symptoms of shock may include weakness, fast heart rate, fast breathing, sweating, anxiety, and increased thirst Shock is divided into four main types based on the underlying cause: hypovolemic, cardiogenic, obstructive, and distributive shock.Hypovolemic shock, also known as low volume shock, may be from bleeding, diarrhea, or vomiting.
One of most common complication of shock is acute kidney injury due to decrease perfusion to kidney which can improved once shock improved
Management :
Aggressive intravenous fluids are recommended in most types of shock (e.g. 1-2 liter normal saline bolus over 10 minutes or 20 mL/kg in a child) which is usually instituted as the person is being further evaluated.[7] Colloids and crystalloids appear to be equally effective with respect to outcomes.,[8] Balanced crystalloids and normal saline also appear to be equally effective in critically ill patients.[9] If the person remains in shock after initial resuscitation, packed red blood cells should be administered to keep the hemoglobin greater than 100 g/L.
Some AKI patients tend to develop volume overload, which should be corrected as early as possible to avoid pulmonary and cardiac complications. Euvolemic state can be achieved with the help of diuretics, which is a cornerstone in managing such patients. Usually, high doses of IV furosemide are needed to correct volume overload in AKI patients; however, it plays no role in converting oliguric AKI to non-oliguric AKI.
In some cases, short-term renal replacement therapy is needed for AKI until the kidney function recovers. Some indications for RRT are severe and non-responsive hyperkalaemia, uremic pericarditis, and pulmonary oedema where the patient is prone to develop multiple electrolyte and acid-base abnormalities as well as fluid overload.
Dialysis in this setting is usually performed through a temporary venous catheter when required. Continuous renal replacement therapy can also be utilized in patients who cannot tolerate haemodialysis due to hypotension. It is a much slower, continuous type of dialysis. . Metabolic acidosis is one such instance where systemic administration of citrate or bicarbonate is often required to maintain a suitable blood pH. The requirement for renal replacement therapy should be re-evaluated daily. Renal replacement therapy is usually required for short periods, ranging from a few days to a few weeks; however, some cases can take months to recover and may require intermittent RRT support.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Safaa Tarek Mohamed Mahmoud, Doctor
- Phone Number: 00201289935619 +201061873774
- Email: safaat048@gmail.com
Study Contact Backup
- Name: Azhar Arabi Mohamed, Doctor
- Phone Number: 00201117862761
- Email: azhararabi@aun.edu.eg
Study Locations
-
-
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Assuit, Egypt
- Assuit university
-
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
Patient with hypovolemic shock affecting kidney function below 18 Years' old.
Exclusion Criteria:
- Patients with kidney function affection due to any type of shock other
Than hypovolemic shock .
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
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Children who have kidney affection after hypovolemic shock
No intervtional drugs or devices at all.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Evaluation of renal affection and its degree in patient with hypovolemic shock
Time Frame: Baseline
|
Detect patient with kidney affection (raised urea ,creatinine and electrolyte)
|
Baseline
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Uchino S, Bellomo R, Goldsmith D, Bates S, Ronco C. An assessment of the RIFLE criteria for acute renal failure in hospitalized patients. Crit Care Med. 2006 Jul;34(7):1913-7. doi: 10.1097/01.CCM.0000224227.70642.4F.
- Hegarty NJ, Young LS, Kirwan CN, O'Neill AJ, Bouchier-Hayes DM, Sweeney P, Watson RW, Fitzpatrick JM. Nitric oxide in unilateral ureteral obstruction: effect on regional renal blood flow. Kidney Int. 2001 Mar;59(3):1059-65. doi: 10.1046/j.1523-1755.2001.0590031059.x.
- Kellum JA, Romagnani P, Ashuntantang G, Ronco C, Zarbock A, Anders HJ. Acute kidney injury. Nat Rev Dis Primers. 2021 Jul 15;7(1):52. doi: 10.1038/s41572-021-00284-z.
Helpful Links
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AKI with hypovolemic shock
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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