Klein 1996.
Study characteristics | ||
Methods | Randomised clinical trial Country: US Multicentre Period of recruitment: May 1992 to April 1994 Number randomised: 118 Postrandomisation dropouts: 10 (8.4%). 3 from the prostaglandin group and 7 from the control group Lost to follow‐up: not reported Inclusion criteria: adults undergoing liver transplantation Exclusion criteria: not reported |
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Participants | Experimental: 58 (27 men and 31 women) Control: 60 (37 men and 23 women) Mean age (years): 45 Women: 54 (46%) |
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Interventions | Experimental: prostaglandin E1 infusion rate of 0.25 μg/kg/hour increased in increments of 0.25 μg/kg/hour every 10 minutes up to a maximum 1 μg/kg/hour. Infusion of study drug continued for 7 days or until the participant transferred out of intensive care unit, whichever occurred first. Maximum dose 80 μg/hour. Control: placebo (normal saline or 5% dextrose) |
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Outcomes |
Creatinine: 1.4 (SD 1.0) mg/dL for prostaglandin group and 2.0 (SD 1.0) mg/dL for control group Blood urea nitrogen: 41.9 (SD 23.7) mg/dL for prostaglandin group and 59.8 (SD 30.5) mg/dL for control group Ammonia: 36.6 (SD 19.4) mmol/L for prostaglandin group and 40.5 (SD 19.9) mmol/L for control group Aspartate aminotransferase: 1152 (SD 1357) IU/L for prostaglandin group and 1574 (SD 2755) IU/L for control group Alanine aminotransferase: 855 (SD 911) IU/L for prostaglandin group and 1170 (SD 1466) IU/L for control group Alkaline phosphatase: 130 (SD 75) IU/L for prostaglandin group and 144 (SD 142) IU/L for control group Bile output: 214 (SD 108) mL/day for prostaglandin group and 234 (SD 141) mL/day for control group Follow‐up (months): 1 |
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Notes | Source of funding: not reported, but the authors' affiliations included Departments of Surgery and Medicine, The Johns Hopkins University School of Medicine, Maryland, US; Departments of Surgery and Pharmacy, Medical University of South Carolina, South Carolina, US; and Departments of Surgery and Pharmacy, University of Virginia Health Sciences Center, Virginia, US. Trial name/trial registry number: not reported. Attempted to contact the authors in December 2020; received no reply. It is unclear if all the authors of publication participated in the trial as information was lacking. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "… randomization was performed centrally by the staff …" |
Allocation concealment (selection bias) | Low risk | Quote: "… who distributed code sealed envelopes to the pharmacies at each participating transplant center." |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Blinding procedures clearly described. Quote: "Control solutions consisted of vehicle (normal saline or 5% dextrose in water) only. Individual solutions were labelled only with respect to the nature of the crystalloid vehicle, with no indication whether they contained prostaglandin E1." |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | End points were mostly observer‐reported outcomes not involving judgement. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Outcomes of all randomised participants provided. |
Selective reporting (reporting bias) | Unclear risk | The study protocol was not available. There was insufficient information to judge this domain. |
Other bias | High risk | Baseline characteristics similar between groups. It was unclear whether trial was stopped early or not because sample size calculation was not published. Intention‐to‐treat analysis was performed. Quote: "At the discretion of the principal investigator, patient with evidence of profoundly deteriorating liver function could either be discontinued from the study or could be discontinued and have open administration started as compassionate therapy." Comment: this causes a high risk of bias and further details of this treatment strategy is not provided in the results. |