Ignite Creation Date:
2024-05-05 @ 11:46 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00124228
Status:
COMPLETED
Last Update Posted:
2010-05-27
First Post:
2005-07-26
Brief Title:
Albumin Administration in Patients With Cirrhosis and Infections Unrelated to Spontaneous Bacterial Peritonitis
Sponsor:
Hospital Clinic of Barcelona
Organization:
Hospital Clinic of Barcelona
Study Overview
Official Title:
Effects of Intravenous Albumin Administration on Renal Function and Survival in Patients With Cirrhosis and Infections Unrelated to Spontaneous Bacterial Peritonitis A Prospective Stratified Randomized and Controlled Study
Status:
COMPLETED
Status Verified Date:
2009-08
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:
Infecir
Brief Summary:
Spontaneous bacterial peritonitis SBP present in cirrhotic patients induces severe circulatory dysfunction which results in renal failure in up to 30 of the patients Renal failure is an important prognostic marker representing the major predictive factor of in-hospital mortality
Recent studies have shown that plasma volume expansion with albumin associated with cefotaxime in patients with SBP is more efficient to prevent renal failure than cefotaxime treatment alone The in-hospital and three-month mortality rates furthermore were significantly lower in the group treated with albumin
It is not known if other bacterial infections unrelated to SBP represent a risk factor for the development of renal failure among cirrhotic patients The researchers group has recently performed a study to evaluate the incidence characteristics and outcome of renal failure in patients with cirrhosis and bacterial infections unrelated to SBP associated with the systemic inflammatory response syndrome Terra unpublished results Among a total of 106 patients 29 27 presented renal failure during the course of infection Renal failure was characterized by intense renal vasoconstriction intrarenal resistive index of 083 - 009 measured by Doppler ultrasound reduction of mean arterial pressure and an important activation of endogenous vasoconstriction systems The three-month survival probability of patients with infection and renal failure was 34 much lower than that of patients with infection but not presenting renal failure 87 p00001 These results suggest that the development of renal failure in patients with cirrhosis and bacterial infections different from SBP associated with signs of a systemic inflammatory response is very frequent and results in a very poor prognosis Taken as a whole these data strongly indicate the need to consider these patients as candidates for liver transplantation and to plan strategies for its prevention
The objective of this project therefore is to evaluate if the plasma volume expansion with albumin associated with conventional antibiotic therapy can prevent the development of renal failure and increase survival rates in cirrhotic patients with bacterial infections unrelated to spontaneous bacterial peritonitis
Recent studies have shown that plasma volume expansion with albumin associated with cefotaxime in patients with SBP is more efficient to prevent renal failure than cefotaxime treatment alone The in-hospital and three-month mortality rates furthermore were significantly lower in the group treated with albumin
It is not known if other bacterial infections unrelated to SBP represent a risk factor for the development of renal failure among cirrhotic patients The researchers group has recently performed a study to evaluate the incidence characteristics and outcome of renal failure in patients with cirrhosis and bacterial infections unrelated to SBP associated with the systemic inflammatory response syndrome Terra unpublished results Among a total of 106 patients 29 27 presented renal failure during the course of infection Renal failure was characterized by intense renal vasoconstriction intrarenal resistive index of 083 - 009 measured by Doppler ultrasound reduction of mean arterial pressure and an important activation of endogenous vasoconstriction systems The three-month survival probability of patients with infection and renal failure was 34 much lower than that of patients with infection but not presenting renal failure 87 p00001 These results suggest that the development of renal failure in patients with cirrhosis and bacterial infections different from SBP associated with signs of a systemic inflammatory response is very frequent and results in a very poor prognosis Taken as a whole these data strongly indicate the need to consider these patients as candidates for liver transplantation and to plan strategies for its prevention
The objective of this project therefore is to evaluate if the plasma volume expansion with albumin associated with conventional antibiotic therapy can prevent the development of renal failure and increase survival rates in cirrhotic patients with bacterial infections unrelated to spontaneous bacterial peritonitis
Detailed Description:
Recent studies have shown that the administration of cefotaxime first choice treatment for SBP associated with plasma volume expansion with albumin in patients with SBP was more efficient to prevent renal failure than cefotaxime treatment alone 10 vs 33 respectively The in-hospital and three-month mortality rates furthermore were significantly lower in the group treated with albumin 10 vs 29 and 22 vs 41 respectively There was a significant increase in the plasma renin activity in the group treated with cefotaxime alone as compared to the group receiving cefotaxime associated with the expansion with albumin A direct relationship between plasma renin activity levels and the development of renal failure was also observed
Based on the previous information the main objective of this study is to evaluate if the plasma volume expansion with albumin associated to conventional antibiotics therapy can prevent the development of renal failure and increase survival rates in cirrhotic patients with bacterial infections unrelated to spontaneous bacterial peritonitis If that proves to be the case albumin should be administered as first choice treatment associated with antibiotics to all the cirrhotic patients with bacterial infection and systemic inflammatory response syndrome
Other parameters to be investigated include
In-hospital mortality
Evaluation of the treatment effects over the renal vascular territory estimated by Doppler ultrasonography of the intrarenal arteries
Evaluation of the relationship between the development of renal failure and the activity of endogenous vasoactive systems plasma renin activity plasma concentration of aldosterone noradrenaline atrial natriuretic factor and nitrites Evaluation of the relationship between the development of renal failure and the concentration of inflammatory cytokines tumor necrosis factor-α interleukin-6 interleukin-1 interleukin-10
Evaluation of heart function and its relationship with the development of renal failure
Based on the previous information the main objective of this study is to evaluate if the plasma volume expansion with albumin associated to conventional antibiotics therapy can prevent the development of renal failure and increase survival rates in cirrhotic patients with bacterial infections unrelated to spontaneous bacterial peritonitis If that proves to be the case albumin should be administered as first choice treatment associated with antibiotics to all the cirrhotic patients with bacterial infection and systemic inflammatory response syndrome
Other parameters to be investigated include
In-hospital mortality
Evaluation of the treatment effects over the renal vascular territory estimated by Doppler ultrasonography of the intrarenal arteries
Evaluation of the relationship between the development of renal failure and the activity of endogenous vasoactive systems plasma renin activity plasma concentration of aldosterone noradrenaline atrial natriuretic factor and nitrites Evaluation of the relationship between the development of renal failure and the concentration of inflammatory cytokines tumor necrosis factor-α interleukin-6 interleukin-1 interleukin-10
Evaluation of heart function and its relationship with the development of renal failure
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
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 |
|---|---|---|---|
| FIS | None | None | None |