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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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
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.

Safaa Tarek Mohamed Mahmoud, Doctor contact

+201061873774 ext. 00201289935619

safaat048@gmail.com

Azhar Arabi Mohamed, Doctor contact

00201117862761

azhararabi@aun.edu.eg

Egypt1 site
  • Assuit university

    Asyut

Other trials in Egypt

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 groups in NCT06612073
Study groupRoleWhat they receive
Children who have kidney affection after hypovolemic shockNo intervtional drugs or devices at all.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

  1. First posted25 Sep 2024
  2. Study startOct 2024 (estimated)
  3. Primary completionOct 2025 (estimated)
  4. Study completionNov 2025 (estimated)

Resources

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)
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 16715038
  • 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.

    PubMed 11231361
  • 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.

    PubMed 34267223

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.

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