The importance of albumin infusion rate for plasma volume expansion following major abdominal surgery – AIR: study protocol for a randomised controlled trial

Table 1 Overview of enrolment, interventions and assessments according to the SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) statement

	Study period
	Enrolment	Allocation	Post-allocation					Close-out
Time point	-t₁	0	t₁	t₂	t₃	t₄	t₅	t₆
Enrolment
Eligibility screen	X
Informed consent	X
Allocation		X
Interventions
Infusion of 5% albumin (10 ml/kg) over 30 minutes				X
Infusion of 5% albumin (10 ml/kg) over 180 minutes				X
Assessments
Plasma volume			X	X	X
Transcapillary escape rate of albumin						X
Haemodynamic data, haematocrit, lactate, ScvO₂	X		X	X	X
Post-operative complications			X	X	X	X	X
Adverse events, serious adverse events			X	X	X	X	X	X

Abbreviations: ScvO ₂ Central venous oxygen saturation, t ₁ Baseline, t ₂ Start of albumin infusion, t ₃ 180 minutes after start of albumin infusion, t ₄ 180–240 minutes after start of albumin infusion, t ₅ 30 days after operation, t ₆ 36 ± 7 days after inclusion or until resolution of any adverse event, serious adverse event or suspected unexpected serious adverse reaction

ISSN: 1745-6215