Ignite Creation Date:
2024-05-06 @ 8:06 PM
Last Modification Date:
2025-12-16 @ 9:08 PM
Study NCT ID:
NCT06256120
Status:
None
Last Update Posted:
2024-11-26 00:00:00
First Post:
2023-12-26 00:00:00
Brief Title:
Effect of Fluid Regimen on Acute Kidney Injury
Sponsor:
Muğla Sıtkı Koçman University
Organization:
Muğla Sıtkı Koçman University
Study Overview
Official Title:
Effects of Peroperative Liberal and Restrictive Fluid Regimens on Protection From Postoperative Acute Kidney Injury in Patients Undergoing Partial or Radical Nephrectomy; Randomized Controlled Trial
Status:
None
Status Verified Date:
2024-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Hypovolemia and organ dysfunction may occur as a result of giving too little fluid during the operation; Giving too much fluid can also cause edema and organ damage. AKI, which develops after kidney surgery, is an important surgical complication and its incidence varies between 5.5% and 34%. Kidney damage is initially subclinical, and its detection is delayed with current diagnostic tools. Due to increased microvascular permeability as a result of excessive fluid administration during the operation, edema in organ tissues and systems may increase infection rates and kidney damage. In a study in which restrictive and free fluid was applied during abdominal aortic aneurysm surgery, they showed that there was deterioration in renal endothelial function in the liberal group; They found that the urine albumin/creatinine ratio increased. In another study, they reported that serum creatinine levels decreased on the first day in patients who underwent colorectal surgery in the group where they applied a liberal fluid regimen; However, they reported that they could not find a significant difference between them and the restrictive group on the following days. It has been shown that restrictive and liberal fluid management applied during abdominal surgery have no effect on renal functions. Although there are few studies in the literature showing that restrictive and liberal fluid regimens applied during abdominal operations affect postoperative renal functions; There are no studies investigating the ideal intraoperative fluid replacement in nephrectomy patients.
It is known that the serum creatinine level, which is routinely used to monitor renal functions, increases late and has poor sensitivity. The reason for this is that it begins to increase 48-72 hours after kidney damage begins and when 50% of functional neurons are lost. Cystatin C, produced by all nucleated cells, is freely filtered by the glomerulus and reabsorbed in the proximal tubule. It is not secreted by renal tubules and does not vary depending on gender, race, weight, changes in muscle mass and nutrition. Serum cystatin C is a biomarker that reflects glomerular filtration rate (GFR) well and can diagnose AKI more accurately than creatinine.
It is known that the serum creatinine level, which is routinely used to monitor renal functions, increases late and has poor sensitivity. The reason for this is that it begins to increase 48-72 hours after kidney damage begins and when 50% of functional neurons are lost. Cystatin C, produced by all nucleated cells, is freely filtered by the glomerulus and reabsorbed in the proximal tubule. It is not secreted by renal tubules and does not vary depending on gender, race, weight, changes in muscle mass and nutrition. Serum cystatin C is a biomarker that reflects glomerular filtration rate (GFR) well and can diagnose AKI more accurately than creatinine.
Detailed Description:
Hypovolemia and organ dysfunction may occur as a result of giving too little fluid during the operation Giving too much fluid can also cause edema and organ damage AKI which develops after kidney surgery is an important surgical complication and its incidence varies between 55 and 34 Kidney damage is initially subclinical and its detection is delayed with current diagnostic tools Due to increased microvascular permeability as a result of excessive fluid administration during the operation edema in organ tissues and systems may increase infection rates and kidney damage In a study in which restrictive and free fluid was applied during abdominal aortic aneurysm surgery they showed that there was deterioration in renal endothelial function in the liberal group They found that the urine albumincreatinine ratio increased In another study they reported that serum creatinine levels decreased on the first day in patients who underwent colorectal surgery in the group where they applied a liberal fluid regimen However they reported that they could not find a significant difference between them and the restrictive group on the following days It has been shown that restrictive and liberal fluid management applied during abdominal surgery have no effect on renal functions Although there are few studies in the literature showing that restrictive and liberal fluid regimens applied during abdominal operations affect postoperative renal functions There are no studies investigating the ideal intraoperative fluid replacement in nephrectomy patients
It is known that the serum creatinine level which is routinely used to monitor renal functions increases late and has poor sensitivity The reason for this is that it begins to increase 48-72 hours after kidney damage begins and when 50 of functional neurons are lost Cystatin C produced by all nucleated cells is freely filtered by the glomerulus and reabsorbed in the proximal tubule It is not secreted by renal tubules and does not vary depending on gender race weight changes in muscle mass and nutrition Serum cystatin C is a biomarker that reflects glomerular filtration rate GFR well and can diagnose AKI more accurately than creatinine
It is known that the serum creatinine level which is routinely used to monitor renal functions increases late and has poor sensitivity The reason for this is that it begins to increase 48-72 hours after kidney damage begins and when 50 of functional neurons are lost Cystatin C produced by all nucleated cells is freely filtered by the glomerulus and reabsorbed in the proximal tubule It is not secreted by renal tubules and does not vary depending on gender race weight changes in muscle mass and nutrition Serum cystatin C is a biomarker that reflects glomerular filtration rate GFR well and can diagnose AKI more accurately than creatinine
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None