Evaluation of Acuty Kidney Injury in Children With Hypovolemic ShockNCT06612073
Evaluation Of The Degree Of Kidney Injury in Children With Hypovolemic Shock
An observational study of Evaluation of Acuty Kidney Injury in Children With Hypovolemic Shock, run by Assiut University at 1 site in Egypt.
Trial summary
To evaluate renal affection and its degree in hypovolemic shocked children Read more about this study
- Who is it for?
- Ages 1 day to 18 years
- Conditions the study is for
- Evaluation of Acuty Kidney Injury in Children With Hypovolemic Shock
- How many people
- 85 participants
- Where
- 1 siteEgypt
- Study dates
- Oct 2024to Nov 2025
- Phase
- Observational
- 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 1 day to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: It is aprospective cohort study to detect acute kidney injury after hypovolemic shock in children from age 1 day till 18 years to help in minimize risk factor .
Who may be able to join
- Patient with hypovolemic shock affecting kidney function below 18 Years' old.
Who cannot join
- Patients with kidney function affection due to any type of shock other
- Than hypovolemic shock .
Trial locations and contacts
1 site in 1 country.
About this study
To evaluate renal affection and its degree in hypovolemic shocked
children
Read the 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.
- Keywords
- AKI in hypovolemic shock
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Children who have kidney affection after hypovolemic shock | No intervtional drugs or devices at all. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of renal affection and its degree in patient with hypovolemic shock
Detect patient with kidney affection (raised urea ,creatinine and electrolyte)
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2024
- Study startOct 2024 (estimated)
- Primary completionOct 2025 (estimated)
- Study completionNov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Evaluation of Acuty Kidney Injury in Children With Hypovolemic ShockStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 85 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Safaa Tarek Mohamed Mahmoud, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06612073
- Sponsor's protocol ID
- AKI with hypovolemic shock
- Status last verified
- Sep 2024
- First submitted
- 21 Sep 2024
- Last updated
- 25 Sep 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 16715038Hegarty 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.
PubMed 11231361Kellum 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.
PubMed 34267223
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation Of The Degree Of Kidney Injury in Children With Hypovolemic Shock
- ClinicalTrials.gov ID
- NCT06612073
- Acronym / sponsor ID
- AKI with hypovolemic shock
- Keywords
- AKI in hypovolemic shock
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 85 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Oct 2024 (estimated)
- Primary completion
- Oct 2025 (estimated)
- Study completion
- Nov 2025 (estimated)
- First posted
- 25 Sep 2024 (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.
To evaluate renal affection and its degree in hypovolemic shocked
children
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children who have kidney affection after hypovolemic shock | – | –No intervtional drugs or devices at all. |
Who may qualify
- Ages
- 1 day to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- It is aprospective cohort study to detect acute kidney injury after hypovolemic shock in children from age 1 day till 18 years to help in minimize risk factor .
Key inclusion criteria (1 listed)
- Patient with hypovolemic shock affecting kidney function below 18 Years' old.
Key exclusion criteria (2 listed)
- Patients with kidney function affection due to any type of shock other
- Than hypovolemic shock .
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2024.
- Background: PubMed 16715038Uchino 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.
- Results publication: PubMed 11231361Hegarty 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.
- Results publication: PubMed 34267223Kellum 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.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Evaluation of Acuty Kidney Injury in Children With Hypovolemic Shock, run by Assiut University at 1 site in Egypt.
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 1 inclusion and 2 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 25 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. 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 Safaa Tarek Mohamed Mahmoud, Doctor (+201061873774 ext. 00201289935619, safaat048@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of renal affection and its degree in patient with hypovolemic shock (time frame: Baseline). 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 NCT06612073, which also lists 3 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 25 Sep 2024.