The combination of octreotide and midodrine is not superior to albumin in preventing recurrence of ascites after large-volume paracentesis.
OBJECTIVE
Large-volume paracentesis (LVP) is the treatment of choice for patients with cirrhosis and refractory ascites. However, LVP can lead to postparacentesis circulatory dysfunction (PCD), which is associated with faster ascites recurrence and renal failure. PCD results from vasodilatation, which reduces effective blood volume, and is prevented by intravenous administration of albumin. Vasoconstrictors could be used instead of albumin and, with longer use, prevent PCD and delay ascites recurrence.


METHODS
We performed a multicenter, randomized, double-blind, placebo-controlled trial to compare albumin with the vasoconstrictor combination of octreotide and midodrine in patients with refractory ascites who underwent LVP. Patients in the albumin group received a single intravenous dose of albumin at the time of LVP plus placebos for midodrine and octreotide (n = 13). Patients in the vasoconstrictor group received saline solution (as a placebo for albumin), 10 mg of oral midodrine (3 times/day), and a monthly 20-mg intramuscular injection of long-acting octreotide (n = 12). Patients were followed up until recurrence of ascites.


RESULTS
The median times to recurrence of ascites were 10 days in the albumin group and 8 days in the vasoconstrictor group (P = .318). There were no significant differences in PCD between the albumin group (18%) and the vasoconstrictor group (25%, P = .574). When ascites recurred, serum levels of creatinine were higher in the vasoconstrictor group (1.2 vs 0.9 mg/dL in the albumin group; P = .051).


CONCLUSIONS
The combination of midodrine and octreotide after LVP is not superior to albumin in delaying recurrence of ascites or preventing PCD in patients with cirrhosis. Outcomes appear to be worse in patients given octreotide and midodrine. ClinicalTrials.gov number, NCT00108355.
Digestive Diseases, Yale University School of Medicine, New Haven, CT 06516, USA.
Khurram
K
Bari
Cecilia
C
Miñano
Martha
M
Shea
Irteza B
IB
Inayat
Hashem J
HJ
Hashem
Hochong
H
Gilles
Douglas
D
Heuman
Guadalupe
G
Garcia-Tsao
D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001201:Ascites / Q000517:prevention & control* / Q000628:therapy*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D008879:Midodrine / Q000008:administration & dosage*; D015282:Octreotide / Q000008:administration & dosage*; D019152:Paracentesis; D010919:Placebos / Q000008:administration & dosage; D011446:Prospective Studies; D055502:Secondary Prevention; D012709:Serum Albumin / Q000008:administration & dosage*; D000075462:Serum Albumin, Human; D016896:Treatment Outcome; D014662:Vasoconstrictor Agents / Q000008:administration & dosage*; D055815:Young Adult
C422455:ALB protein, human; D010919:Placebos; D012709:Serum Albumin; D014662:Vasoconstrictor Agents; D008879:Midodrine; D015282:Octreotide; D000075462:Serum Albumin, Human