Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00026702
Status:
RECRUITING
Last Update Posted:
2024-06-13
First Post:
2001-11-14
Brief Title:
Search for New Methods to Detect Acute Renal Failure
Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases NIDDK
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Search for Novel Methods to Detect Acute Renal Failure
Status:
RECRUITING
Status Verified Date:
2024-03-22
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:
The purpose of this study is to find substances in the blood and urine that indicate that a person has kidney damage It will identify proteins found only in patients with acute kidney failure but not in normal healthy people or in patients with volume depletion
Adults and children who are at least 3 years old who fall into one of the following four categories may be eligible for this study
1 Are healthy and have normal kidney function
2 Have volume depletion this condition differs from acute kidney failure in that it is easily treated with fluids
3 Are at high risk of kidney failure
4 Have acute kidney failure kidney shutdown
All study participants will have a history and physical examination Up to four blood samples of 3 tablespoons each will be taken for laboratory analysis Urine will be collected for analysis and to measure urine output The participants length of stay in the study varies People with normal kidney function will be in the study for 1 day and patients with volume depletion will be studied 3 days The length of hospitalization of patients at high risk of kidney failure or in acute kidney failure will depend on the patient s condition and medication requirements
The results of this study may lead to the development of earlier and more accurate methods for diagnosing acute kidney failure With earlier detection treatment could be started earlier possibly preventing further damage and helping recovery of injury that has already occurred
Adults and children who are at least 3 years old who fall into one of the following four categories may be eligible for this study
1 Are healthy and have normal kidney function
2 Have volume depletion this condition differs from acute kidney failure in that it is easily treated with fluids
3 Are at high risk of kidney failure
4 Have acute kidney failure kidney shutdown
All study participants will have a history and physical examination Up to four blood samples of 3 tablespoons each will be taken for laboratory analysis Urine will be collected for analysis and to measure urine output The participants length of stay in the study varies People with normal kidney function will be in the study for 1 day and patients with volume depletion will be studied 3 days The length of hospitalization of patients at high risk of kidney failure or in acute kidney failure will depend on the patient s condition and medication requirements
The results of this study may lead to the development of earlier and more accurate methods for diagnosing acute kidney failure With earlier detection treatment could be started earlier possibly preventing further damage and helping recovery of injury that has already occurred
Detailed Description:
The mortality of acute renal failure ARF remains high despite advances in supportive care There are no established effective drug therapies and dialysis may promote renal injury via hypotension or neutrophil activation Many agents eg mannitol furosemide dopamine Atrial Natriuretic Peptide ANP Insulin-like Growth Factor IGF-1 thyroid hormone etc are effective in animal models but ineffective in treating or preventing human ARF The failure of these agents in human ARF may be due to late enrollment into the trial effective therapy will likely require earlier detection
The objective of this clinical study is to identify new biomarkers of renal injury progression or recovery by analyzing urinary proteins during ARF We will enroll patients with ARF patients at high risk of ARF patients with volume depletion patients with urinary tract infection patients with chronic kidney disease and normal subjects The diagnosis of pre-renal versus renal ARF will be made by routine clinical and laboratory testing The level of renal dysfunction will be determined by creatinine clearance Those patients at high risk for ARF will be followed prospectively and will undergo additional testing if ARF does develop Patients will also be studied after creatinine levels return to normal We will identify protein andor microRNA biomarkers that are unique to patients with ARFbut not found in normal subjects or patients with volume depletion It is hoped that some of these proteins may form the basis of new diagnostic tests for ARF
The objective of this clinical study is to identify new biomarkers of renal injury progression or recovery by analyzing urinary proteins during ARF We will enroll patients with ARF patients at high risk of ARF patients with volume depletion patients with urinary tract infection patients with chronic kidney disease and normal subjects The diagnosis of pre-renal versus renal ARF will be made by routine clinical and laboratory testing The level of renal dysfunction will be determined by creatinine clearance Those patients at high risk for ARF will be followed prospectively and will undergo additional testing if ARF does develop Patients will also be studied after creatinine levels return to normal We will identify protein andor microRNA biomarkers that are unique to patients with ARFbut not found in normal subjects or patients with volume depletion It is hoped that some of these proteins may form the basis of new diagnostic tests for ARF
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 00-DK-0107 | None | None | None |