Ignite Creation Date:
2024-05-06 @ 7:48 PM
Last Modification Date:
2024-10-26 @ 3:14 PM
Study NCT ID:
NCT06143098
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-02-20
First Post:
2023-11-14
Brief Title:
Some Hematological Profile in Children With Chronic Kidney Disease
Sponsor:
Assiut University
Organization:
Assiut University
Study Overview
Official Title:
Some Hematological Profile in Children With Chronic Kidney Disease
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-02
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:
This study is asses the hematological changes in children with chronic kidney disease stage 3 to 5 including
Complete blood picture
Coagulation profile PT PC PTT
Iron study
Complete blood picture
Coagulation profile PT PC PTT
Iron study
Detailed Description:
Chronic kidney disease CKD is a major public health issue with an increasing incidence and prevalence worldwide In CKD hematological parameters are influenced it is associated with high morbidity and mortality rates but there have been very few studies on the hematological profile of children with chronic kidney disease on follow-up in general and particularly among chronic kidney disease patientsMelakuet al 2022
CKD is defined by the presence of kidney damage or an estimated glomerular filtration rate eGFR less than 60 mlmin173 m2 it can last for 3 months or longer regardless of the cause Chronic kidney disease CKD is recognized as a major non-communicable disease in children Inkeret al2014
CKD is classifies it into 6 categories based on glomerular filtration rate G1 to G5 with G3 split into 3a and 3b It also includes the staging based on three levels of albuminuria A1 A2 and A3 with each stage of CKD being sub-categorized according to the urinary albumin-creatinine ratio in mggm or mgmmol in an early morning spot urine sample Inkeret al 2012
The 6 categories include
G1 GFR 90 mlmin per 173 m2 and above
G2 GFR 60 to 89 mlmin per 173 m2
G3a GFR 45 to 59 mlmin per 173 m2
G3b GFR 30 to 44 mlmin per 173 m2
G4 GFR 15 to 29 mlmin per 173 m2
G5 GFR less than 15 mlmin per 173 m2 or treatment by dialysis The three levels of albuminuria include an albumin-creatinine ratio ACR
A1 ACR less than 30 mggm less than 34 mgmmol
A2 ACR 30 to 299 mggm 34 to 34 mgmmol
A3 ACR greater than 300 mggm greater than 34 mgmmol Inkeret al2014 hematological parameters such as white blood cell WBC include total leukocyte and differential counts platelet PLT and red blood cell RBC Parameters Kidney function electrolytes such as Nakca and liver function bleeding time and pro-thrombin time are usually affected in CKD These are common in CKD due to erythropoietin deciency and other factors such as increased hemolysis suppression of bone marrow erythropoiesis hematuria and gastro intestinal blood loss Georgeet al2015
All CKD patients particularly those with an estimated GFR eGFR 60 mLmin173 m2 should be screened for anemia on initial evaluation for CKD Anemia is defined as Hb 13 gdL in men and Hb 12 gdL in women according to WHO criteria Hira Shaikhet al 2023
the primary cause of anemia in patients with CKD is insufficient production of erythropoietin by the diseased kidneys Other factors include iron folate B12 deficiency due to nutritional insufficiency or increased blood loss Hira Shaikhet al 2023 acute and chronic inflammation with impaired iron utilization sever hyperparathyroidism with consequent bone marrow fibrosis and shortened red cell survival in the uremic environment bleeding due to dysfunctional platelets and rarely blood loss from hemodialysisHira Shaikhet al 2023
Criteria used to define iron deficiency are different among CKD compared to normal renal function Among CKD patients absolut iron deficiency is defined when the transferrin saturation TSAT is 20 and the serum ferritin concentration is 100 ngmL among predialysis and peritoneal dialysis patients or 200 ngmL among hemodialysis patients Functional iron deficiency also known as iron-restricted erythropoiesis is characterized by TSAT 20 and elevated ferritin levels TSAT plasma iron divided by the total iron-binding capacity 100 Cappellini et al 2017
untreated prolonged anemia leads to a number of physiologic disorders including cardiovascular complications like decreased tissue oxygenation increased cardiac output ventricular dilatation and ventricular hypertrophy and increased mortality and morbidity Dwijen Das et al 2015
Iron supplementation is recommended for all CKD patients with anemia There is general agreement according to guidelines that intravenous iv iron supplementation is the preferred method for CKD patients on dialysis CKD stage 5D and either iv or oral iron is recommended for patients with CKDTolkienet al 2015
CKD is defined by the presence of kidney damage or an estimated glomerular filtration rate eGFR less than 60 mlmin173 m2 it can last for 3 months or longer regardless of the cause Chronic kidney disease CKD is recognized as a major non-communicable disease in children Inkeret al2014
CKD is classifies it into 6 categories based on glomerular filtration rate G1 to G5 with G3 split into 3a and 3b It also includes the staging based on three levels of albuminuria A1 A2 and A3 with each stage of CKD being sub-categorized according to the urinary albumin-creatinine ratio in mggm or mgmmol in an early morning spot urine sample Inkeret al 2012
The 6 categories include
G1 GFR 90 mlmin per 173 m2 and above
G2 GFR 60 to 89 mlmin per 173 m2
G3a GFR 45 to 59 mlmin per 173 m2
G3b GFR 30 to 44 mlmin per 173 m2
G4 GFR 15 to 29 mlmin per 173 m2
G5 GFR less than 15 mlmin per 173 m2 or treatment by dialysis The three levels of albuminuria include an albumin-creatinine ratio ACR
A1 ACR less than 30 mggm less than 34 mgmmol
A2 ACR 30 to 299 mggm 34 to 34 mgmmol
A3 ACR greater than 300 mggm greater than 34 mgmmol Inkeret al2014 hematological parameters such as white blood cell WBC include total leukocyte and differential counts platelet PLT and red blood cell RBC Parameters Kidney function electrolytes such as Nakca and liver function bleeding time and pro-thrombin time are usually affected in CKD These are common in CKD due to erythropoietin deciency and other factors such as increased hemolysis suppression of bone marrow erythropoiesis hematuria and gastro intestinal blood loss Georgeet al2015
All CKD patients particularly those with an estimated GFR eGFR 60 mLmin173 m2 should be screened for anemia on initial evaluation for CKD Anemia is defined as Hb 13 gdL in men and Hb 12 gdL in women according to WHO criteria Hira Shaikhet al 2023
the primary cause of anemia in patients with CKD is insufficient production of erythropoietin by the diseased kidneys Other factors include iron folate B12 deficiency due to nutritional insufficiency or increased blood loss Hira Shaikhet al 2023 acute and chronic inflammation with impaired iron utilization sever hyperparathyroidism with consequent bone marrow fibrosis and shortened red cell survival in the uremic environment bleeding due to dysfunctional platelets and rarely blood loss from hemodialysisHira Shaikhet al 2023
Criteria used to define iron deficiency are different among CKD compared to normal renal function Among CKD patients absolut iron deficiency is defined when the transferrin saturation TSAT is 20 and the serum ferritin concentration is 100 ngmL among predialysis and peritoneal dialysis patients or 200 ngmL among hemodialysis patients Functional iron deficiency also known as iron-restricted erythropoiesis is characterized by TSAT 20 and elevated ferritin levels TSAT plasma iron divided by the total iron-binding capacity 100 Cappellini et al 2017
untreated prolonged anemia leads to a number of physiologic disorders including cardiovascular complications like decreased tissue oxygenation increased cardiac output ventricular dilatation and ventricular hypertrophy and increased mortality and morbidity Dwijen Das et al 2015
Iron supplementation is recommended for all CKD patients with anemia There is general agreement according to guidelines that intravenous iv iron supplementation is the preferred method for CKD patients on dialysis CKD stage 5D and either iv or oral iron is recommended for patients with CKDTolkienet al 2015
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