NGAL and Renal Resistive Index in the Diagnosis and Prognosis of Sepsis-associated AKI

NCT05374759 | Completed

• 1 other identifier: AOzer3
• Study Type: observational
• Target: 101
• Locations: 1 country
• Sites: 1

Brief Summary

AKI develops frequently in patients hospitalized in the intensive care unit, and the biggest risk factor is sepsis. Creatine, which is traditionally used in the diagnosis of AKI, is affected by many factors, causes the diagnosis to be delayed, and its effect in showing the prognosis is limited. Therefore, there is a need to search for new parameters for early diagnosis and prediction of prognosis. Although many biomarkers studied in blood and urine have been reported in the literature, NGAL has been the most emphasized in terms of both diagnosis and prognosis. Although there are publications on the use of the renal resistive index in the diagnosis in new studies, the place of RRI in the diagnosis has not been determined exactly, and its effect on the prognosis has not been studied. In our study, renal resistive index will be measured by renal ultrasonography at the bedside in patients with sepsis at the time of diagnosis, and NGAL will be studied from the blood of the patients, and their values will be compared in terms of detecting patients with AKI in sepsis and showing prognosis. In summary, if the renal resistive index is superior to serum NGAL and parameters such as creatinine level in showing the diagnosis and prognosis of AKI; Early planning of the patient's treatment with a bedside and non-invasive method will also reduce the cost, considering that ultrasonography is now indispensable for all intensive care units.

Conditions

Sepsis; Acute Kidney Injury

Outcome Measures

Primary Outcomes (4)

• NGAL

  Blood NGAL

  at diagnosis

• NGAL

  Blood NGAL

  at the third days

• Renal resistive index

  renal resistive index guided ultrasound

  at diagnosis

• Renal resistive index

  renal resistive index guided ultrasound

  at the third days

Study Arms (2)

Group 1

Patients with sepsis who develop AKI

Diagnostic Test: neutrophil gelatinase-associated lipocalin; Diagnostic Test: renal resistive index

Group 2

Patients with sepsis who do not develop AKI

Diagnostic Test: neutrophil gelatinase-associated lipocalin; Diagnostic Test: renal resistive index

Interventions

neutrophil gelatinase-associated lipocalin DIAGNOSTIC_TEST

When the patient is diagnosed with sepsis and on the 3rd day of the follow-up, blood samples will be taken and NGAL levels will measured.

Group 1; Group 2

renal resistive index DIAGNOSTIC_TEST

When the patient is diagnosed with sepsis and on the 3rd day of the follow-up, renal resistive index will measure and record.

Group 1; Group 2

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients with sepsis in ICU.

You may qualify if:

• sepsis
• septic shock

You may not qualify if:

• Weak abdominal echogenicity age \< 18, other conditions causing shock (hypovolemic, cardiogenic, neurogenic), having a life expectancy of less than 24 hours, pregnancy, vasospastic disease, intraperitoneal pressure \> 15 mm Hg, obstructive renal failure or suspected, presence of arrhythmia, presence of renal artery stenosis, kidney transplant patients presence of kidney tumor patients receiving dialysis treatment, solitary kidney and other kidney abnormalities, presence of coronary artery disease, presence of acute mesenteric ischemia, Those who have been using drugs that inhibit angiotensin converting enzyme (ACE) and angiotensin receptor blockers for the last 48 hours, Patients with severe acute or chronic renal failure defined as glomerular filtration rate (GFR) \< 30 ml/min/1.73 m2

Sponsors & Collaborators

• Inonu University: lead

Study Sites (1)

Ayse Belin B OZER

Malatya, Turkey (Türkiye)

Location

Related Publications (3)

• Faubel S, Patel NU, Lockhart ME, Cadnapaphornchai MA. Renal relevant radiology: use of ultrasonography in patients with AKI. Clin J Am Soc Nephrol. 2014 Feb;9(2):382-94. doi: 10.2215/CJN.04840513. Epub 2013 Nov 14.

  PMID: 24235286 BACKGROUND

• Renberg M, Jonmarker O, Kilhamn N, Rimes-Stigare C, Bell M, Hertzberg D. Renal resistive index is associated with acute kidney injury in COVID-19 patients treated in the intensive care unit. Ultrasound J. 2021 Feb 5;13(1):3. doi: 10.1186/s13089-021-00203-z.

  PMID: 33544258 BACKGROUND

• Haitsma Mulier JLG, Rozemeijer S, Rottgering JG, Spoelstra-de Man AME, Elbers PWG, Tuinman PR, de Waard MC, Oudemans-van Straaten HM. Renal resistive index as an early predictor and discriminator of acute kidney injury in critically ill patients; A prospective observational cohort study. PLoS One. 2018 Jun 11;13(6):e0197967. doi: 10.1371/journal.pone.0197967. eCollection 2018.

  PMID: 29889830 BACKGROUND

MeSH Terms

Conditions

Sepsis; Acute Kidney Injury

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Study Record Dates

• First Submitted: April 29, 2022
• First Posted: May 16, 2022
• Study Start: May 11, 2022
• Primary Completion: November 11, 2022
• Study Completion: December 11, 2022
• Last Updated: November 3, 2023

Record last verified: 2023-11

Locations

TU (1)