Trial Outcomes & Findings for Vasoconstrictors as Alternatives to Albumin After Large-Volume Paracentesis (LVP) in Cirrhosis (NCT NCT00108355)
NCT ID: NCT00108355
Last Updated: 2014-03-06
Results Overview
Comparison between Albumin (Control group) and Vasoconstrictor (Treatment group)
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
29 participants
Primary outcome timeframe
Variable depending on the patient, average 10 days
Results posted on
2014-03-06
Participant Flow
Between October 2003 and June 2010, about 200 patients with cirrhosis and ascites were screened, of which, only 29 met inclusion criteria. Twenty five patients (13 control, 12 study group) were included in the analysis.
Participant milestones
| Measure |
Albumin (Control Group)
After LVP, patients in this group received:
Intravenous albumin (25%) at 8 g/liter of ascitic fluid removed, one time dose; Intramuscular injection of 5 cc saline (Octreotide LAR placebo), every 30 days ; Oral tablet 3 times a day (Midodrine placebo)
|
Vasoconstrictors (Study Group)
After LVP, patients in this group received:
Octreotide LAR intramuscular injection 20 mg, every 30 days; Midodrine tablet, 10 mg three times a day; Intravenous saline infusion (Albumin placebo), one time dose
|
|---|---|---|
|
Overall Study
STARTED
|
15
|
14
|
|
Overall Study
COMPLETED
|
13
|
12
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
Reasons for withdrawal
| Measure |
Albumin (Control Group)
After LVP, patients in this group received:
Intravenous albumin (25%) at 8 g/liter of ascitic fluid removed, one time dose; Intramuscular injection of 5 cc saline (Octreotide LAR placebo), every 30 days ; Oral tablet 3 times a day (Midodrine placebo)
|
Vasoconstrictors (Study Group)
After LVP, patients in this group received:
Octreotide LAR intramuscular injection 20 mg, every 30 days; Midodrine tablet, 10 mg three times a day; Intravenous saline infusion (Albumin placebo), one time dose
|
|---|---|---|
|
Overall Study
Peritonitis at index paracentesis
|
1
|
1
|
|
Overall Study
Loculated ascites, limiting paracentesis
|
1
|
1
|
Baseline Characteristics
Vasoconstrictors as Alternatives to Albumin After Large-Volume Paracentesis (LVP) in Cirrhosis
Baseline characteristics by cohort
| Measure |
Albumin (Control Group)
n=13 Participants
After LVP, patients in this group received:
Intravenous albumin (25%) at 8 g/liter of ascitic fluid removed, one time dose; Intramuscular injection of 5 cc saline (Octreotide LAR placebo), every 30 days ; Oral tablet 3 times a day (Midodrine placebo)
|
Vasoconstrictor (Treatment Group)
n=12 Participants
After LVP, patients in this group received:
Octreotide LAR intramuscular injection 20 mg, every 30 days; Midodrine tablet, 10 mg three times a day; Intravenous saline infusion (Albumin placebo), one time dose
|
Total
n=25 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
11 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Age, Continuous
age median
|
55 years
INTER_QUARTILE_RANGE 7.5 • n=5 Participants
|
60 years
INTER_QUARTILE_RANGE 8.4 • n=7 Participants
|
58 years
INTER_QUARTILE_RANGE 8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
13 participants
n=5 Participants
|
12 participants
n=7 Participants
|
25 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Variable depending on the patient, average 10 daysComparison between Albumin (Control group) and Vasoconstrictor (Treatment group)
Outcome measures
| Measure |
Albumin (Control Group)
n=13 Participants
After LVP, patients in this group received:
Intravenous albumin (25%) at 8 g/liter of ascitic fluid removed, one time dose; Intramuscular injection of 5 cc saline (Octreotide LAR placebo), every 30 days ; Oral tablet 3 times a day (Midodrine placebo)
|
Vasoconstrictor (Treatment Group)
n=12 Participants
After LVP, patients in this group received:
Octreotide LAR intramuscular injection 20 mg, every 30 days; Midodrine tablet, 10 mg three times a day; Intravenous saline infusion (Albumin placebo), one time dose
|
|---|---|---|
|
Time to Recurrence of Ascites.
|
10 days
Interval 7.0 to 29.0
|
8 days
Interval 6.0 to 22.0
|
SECONDARY outcome
Timeframe: 6 days after paracentesisPopulation: Plasma Renin Activity (lab value to measure PCD) was not available for 6 patients leaving 11 patients in Albumin (control group) and 8 patients in Vasoconstrictor (Treatment group) for this outcome analysis.
Defined as an increase in Plasma Renin Activity (PRA) by \>50% from baseline to a level \> 4 ng/mL/h at post-paracentesis day
Outcome measures
| Measure |
Albumin (Control Group)
n=11 Participants
After LVP, patients in this group received:
Intravenous albumin (25%) at 8 g/liter of ascitic fluid removed, one time dose; Intramuscular injection of 5 cc saline (Octreotide LAR placebo), every 30 days ; Oral tablet 3 times a day (Midodrine placebo)
|
Vasoconstrictor (Treatment Group)
n=8 Participants
After LVP, patients in this group received:
Octreotide LAR intramuscular injection 20 mg, every 30 days; Midodrine tablet, 10 mg three times a day; Intravenous saline infusion (Albumin placebo), one time dose
|
|---|---|---|
|
Development of Post-paracentesis Circulatory Dysfunction (PCD)
|
2 participants
|
2 participants
|
Adverse Events
Albumin (Control Group)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Vasoconstrictor (Treatment Group)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Albumin (Control Group)
n=13 participants at risk
After LVP, patients in this group received:
Intravenous albumin (25%) at 8 g/liter of ascitic fluid removed, one time dose; Intramuscular injection of 5 cc saline (Octreotide LAR placebo), every 30 days ; Oral tablet 3 times a day (Midodrine placebo)
|
Vasoconstrictor (Treatment Group)
n=12 participants at risk
After LVP, patients in this group received:
Octreotide LAR intramuscular injection 20 mg, every 30 days; Midodrine tablet, 10 mg three times a day; Intravenous saline infusion (Albumin placebo), one time dose
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/13
|
16.7%
2/12 • Number of events 2
|
|
Gastrointestinal disorders
GI Bleeding
|
7.7%
1/13 • Number of events 1
|
0.00%
0/12
|
|
Hepatobiliary disorders
Hepatic encephalopathy
|
7.7%
1/13 • Number of events 1
|
0.00%
0/12
|
|
Renal and urinary disorders
Scrotal edema
|
7.7%
1/13 • Number of events 1
|
8.3%
1/12 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
0.00%
0/13
|
8.3%
1/12 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place