What is the evidence for use of vasopressin in potential organ donors?

Comment by InpharmD Researcher

Evidence for the use of vasopressin or desmopressin (synthetic vasopressin analog) in brain-dead organ donors is primarily limited to studies published in the 1990s that have observed reduced diuresis and improved hemodynamics following administration. Despite their observed benefits, vasopressin or desmopressin do not appear to have any clinical benefit on long-term graft function. A consensus upon dosing and concentrations is generally lacking, but based on available studies, vasopressin at a dose range of 0.5 to 2.4 units/hour titrated to blood pressure (goal MAP 60-70 mmHg and central venous pressure 6-10 mmHg) and urine output (1-3 mL/kg/hour) has been recommended. Doses up to 4 units/hour have also been suggested, but there is concern that potentially deleterious vasoconstriction of renal, mesenteric, pulmonary, and coronary vasculature could occur at higher doses. Various doses are suggested for desmopressin ranging from 0.5 mcg to 6 mcg given at different intervals, titrated to a urine output <3 mL/kg/hour. Unfortunately, published protocols with respective titration parameters for vasopressin/desmopressin in this setting appear to be lacking.

Background

A 2013 meta-analysis evaluates the efficacy of interventions used to stabilize hemodynamics in brain-dead donors or to improve organ function and outcomes of transplantation. Of the interventions evaluated, a total of two studies (n= 121) included in the analysis evaluated the use of desmopressin, a synthetic form of vasopressin. In one study, a total of 97 brain-dead donors received desmopressin as 1 mcg bolus every 2 hours if they were diagnosed as having diabetes insipidus with a diuresis of more than 300 mL/h. Desmopressin was discontinued 2 hours before organ harvesting. Patients in the control group received no desmopressin. No significant differences were found between the two groups of brain-dead donors, except for final diuresis, which was lower in the desmopressin group than the control group (0.38 L/h vs. 0.70 L/h; p= 0.0001). Hemodialysis requirements and serum creatinine concentrations also did not differ between the two groups 15 days after transplantation, and long-term graft survival was similar in both groups (88% vs. 87%). [1], [2]

In the other study, a total of 24 brain-dead organ donors were assessed based on the use of a control or desmopressin. Initially, in patients who had a central venous pressure (CPV) <8 mm Hg received lactated Ringer’s solution until a CVP of 8 mmHg was attained, and dextrose 5% was administered at 80 mL/hour. Patients in whom the urine output exceeded 3 mL/kg/hr for 2 successive hours were treated with desmopressin 2 mg IV. The treatment was repeated if the urine output again exceeded 3 mL/kg/hr for 2 successive hours. Patients received additional treatment with oxygen and dopamine to maintain a mean arterial pressure (MAP) of 65 to 85 mmHg. When patients were hemodynamically stable at the goal MAP, patients were randomized to receive either a 300 microunit/kg/min infusion of arginine vasopressin (AVP) or a saline infusion. Use of AVP significantly decreased plasma hyperosmolality, increased blood pressure, decreased inotrope use, and maintained cardiac output. The control group, however, experienced no significant changes in blood pressure, cardiac output, or inotrope infusion rate. Overall, early organ function was similar between the two groups. [1], [2], [3]

Pooled data from these two studies within the meta-analysis found no benefit for desmopressin on early graft function of kidney transplants (relative risk 0.97; 95% confidence interval 0.85 to 1.10). While the use of desmopressin was not associated with better kidney graft outcomes, its safe and effective use for limiting the harmful effects of profuse polyuria, decreasing the need for large-volume infusions, and preventing hemodynamic collapse, were deemed as potential benefits for using desmopressin in the organ donor setting. [1]

A 2019 review article assessed the benefits of using hormonal therapy, including vasopressin, in brain-dead donors to optimize recipient outcomes. Hypotension and diabetes insipidus, conditions that commonly occur in brain-dead patients, can lead to donor instability due to inadequate organ perfusion. Diabetes insipidus in these donors can be managed by either vasopressin or the synthetic vasopressin analog (1-d-amino-8-d-arginine vasopressin [DDAVP]), which is also referred to as desmopressin. DDAVP is the preferred agent for treating diabetes insipidus in the absence of hypotension due to being highly selective for the V2 renal receptors; it may be administered as an intravenous (IV) bolus of 2 to 6 mcg every 6 to 8 hours or as needed. There is some concern that DDAVP at lower doses (<0.3 mcg/kg) may be procoagulant and detrimental to pancreatic and renal graft transplant function, however, reports on effects on transplant outcomes are inconsistent. [4]

Vasopressin may be used for the treatment of both diabetes insipidus and hypotension due to its activity at both the V2 renal receptors and the V1 receptors on vascular smooth muscle; it must be administered via IV infusion due to its shorter half-life than DDAVP (10 to 35 min). The typically used vasopressin dose range is 0.5 to 2.4 units per hour, titrated to blood pressure and urine output. Doses up to 4 units per hour have been suggested in some guidelines, but there is concern that doses greater than 0.04 units per minute could cause potentially deleterious vasoconstriction of renal, mesenteric, pulmonary, and coronary vasculature. [4]

There is a lack of well-studied comparisons between the use of different vasoactive agents in organ donors. One retrospective registry analysis study in the United States found vasopressin was associated with a higher number of organs received per donor. Norepinephrine is the most commonly used vasoactive agent used in Australia and New Zealand for blood pressure management in donors. In conclusion, the authors of the review suggest vasopressin as the preferred agent if donors have both diabetes insipidus and hypotension. Desmopressin may also be used concurrently with vasopressin if the vasopressin dose required for blood pressure support is not sufficient to also control diabetes insipidus. [4], [5]

According to a 2019 guideline published by the Intensive Care Society of Ireland, vasopressin is recommended first-line for the vasodilatory shock state associated with brain death at a dose of 0.5 to 2.4 IU/h. This low dose of vasopressin is suggested to aid restoration of vascular tone and treat diabetes insipidus via an antidiuretic effect in the distal nephron. The guidelines also provide detailed management of diabetes insipidus in the setting of organ donation. Following replacement of ongoing fluid losses and any existing fluid deficit with hypotonic fluid, if urine output is > 3 mL/kg/h, an infusion of IV vasopressin and/or intermittent subcutaneous or IV DDAVP is recommended. If vasopressor support is required, IV vasopressin should be infused at a rate of 0.5-2.4 IU/h. However, vasopressin alone often is not adequate to control diuresis, and DDAVP should be given as soon as diabetes insipidus is suspected. DDAVP is an analog of arginine vasopressin with enhanced antidiuretic potency, negligible vasopressor activity, and a prolonged half-life compared to vasopressin. The recommended dose of DDAVP in adults is 1-2 mcg subcutaneously or IV followed by 1-2 mcg subcutaneously or IV as required to achieve a urine output <3 mL/kg/h. Overall, hemodynamic goals should include a blood pressure maintained at a MAP of 60-70 mmHg, central venous pressure of 6-10 mmHg, and urine output of 1-3 mL/kg/h. [6]

Another review published in 2016 describing the management of organ donors after brain death suggests that in donors with diabetes insipidus who are at high risk of developing hypovolemia or continue to be hypotensive despite crystalloid repletion, vasopressin can be initiated with a bolus of 1 unit followed by a continuous infusion of 0.5-4 units/hr. Desmopressin, a synthetic vasopressin analog, has a longer duration of action and a decreased vasoconstrictor effect compared to vasopressin. It is recommended to be given at a rate of 0.5-2.0 mcg/hr every 2-3 hours adjusted to achieve a urine output goal of 1-3 mL/kg/hr. [7]

A randomized controlled trial published in 1998 evaluated use of desmopressin in brain-dead donors and analyzed early and long-term graft function in kidney recipients. Brain-dead donors were randomized to receive control (n= 48) or desmopressin (n= 49) administered as an intravenous bolus of 1 mcg every 2 hours for diuresis greater than 300 mL/h. Overall, no significant differences were noted between the control and desmopressin groups of brain-dead donors, except for final diuresis, which was lower in the desmopressin group (0.38 ± 0.30 vs. 0.70 ± 0.54 mL/h, p<0.05). Of 174 kidney recipients analyzed (89 in the control group and 86 in the desmopressin group), the rate of hemodialysis during the early post-transplantation was not significantly different between the two groups (20% vs. 23%) nor was the serum creatinine concentrations over a 15-day period post-transplantation. Long-term results of kidney transplantation between the two groups did not differ. It was demonstrated that desmopressin can be safely administered in brain-dead donors to limit the deleterious consequences of diabetes insipidus, but the clinical significance may be limited. Limited information could be obtained from this study, as it is only available in abstract form. [8]

References:

[1] Rech TH, Moraes RB, Crispim D, Czepielewski MA, Leitão CB. Management of the brain-dead organ donor: a systematic review and meta-analysis. Transplantation. 2013;95(7):966-974. doi:10.1097/TP.0b013e318283298e
[2] Guesde R, Barrou B, Leblanc I, et al. Administration of desmopressin in brain-dead donors and renal function in kidney recipients. Lancet. 1998;352(9135):1178-1181. doi:10.1016/S0140-6736(98)05456-7
[3] Pennefather SH, Bullock RE, Mantle D, Dark JH. Use of low dose arginine vasopressin to support brain-dead organ donors. Transplantation. 1995;59(1):58-62. doi:10.1097/00007890-199501150-00011
[4] Opdam HI. Hormonal Therapy in Organ Donors. Crit Care Clin. 2019;35(2):389-405. doi:10.1016/j.ccc.2018.11.013
[5] Plurad DS, Bricker S, Neville A, Bongard F, Putnam B. Arginine vasopressin significantly increases the rate of successful organ procurement in potential donors. Am J Surg. 2012;204(6):856-861. doi:10.1016/j.amjsurg.2012.05.011
[6] Conrick-Martin I, Gaffney A, Dwyer R, O'Loughlin C, Colreavy F; Intensive Care Society of Ireland. Intensive Care Society of Ireland - Guidelines for management of the potential organ donor (2018-2nd edition). Ir J Med Sci. 2019;188(4):1111-1118. doi:10.1007/s11845-019-01987-9
[7] Korte C, Garber JL, Descourouez JL, Richards KR, Hardinger K. Pharmacists' guide to the management of organ donors after brain death. Am J Health Syst Pharm. 2016;73(22):1829-1839. doi:10.2146/ajhp150956
[8] Ourahma S, Guesde R, Leblanc I, et al. Administration of desmopressin in brain-dead donors does not modify renal function in kidney recipients. Transplant Proc. 1998;30(6):2844. doi:10.1016/s0041-1345(98)00834-3

Literature Review

A search of the published medical literature revealed 1 study investigating the researchable question:

What is the evidence for use of vasopressin in potential organ donors? What is the recommended dosing & concentration? Are there any published examples of protocols and titration parameters?

Please see Table 1 for your response.


 

The effect of arginine vasopressin on organ donor procurement and lung function

Design

Retrospective study 

N= 12,322

Objective

To test the hypothesis that arginine vasopressin (AVP) is associated with the maintenance of lung function and successful recovery in donors and enhanced lung graft performance in recipients

Study Groups

AVP (n= 7,686)

No AVP (n= 4,636)

Inclusion Criteria

Those diagnosed with brain death who received hormone replacement therapy (HRT) having any organ successfully procured which also included expanded criteria donors (ECD) (age 60 years without comorbidities or 50-59 years with comorbidities) and Centers for Disease Control (CDC) high-risk (history of IV drug use, hemophilia, high-risk sexual activity, exposure to human immunodeficiency virus, and jail sentencing) donors

Exclusion Criteria

Not specified

Methods

The Organ Procurement and Transplantation Network (OPTN) deceased donor and thoracic recipient databases were used as data sources. HRT was defined as an infusion of dextrose, insulin, methylprednisolone, and thyroid hormone during resuscitation. Lung donors were matched to their recipients and outcomes were compared between transplanted patients who received a lung graft from either an AVP (+) or an AVP (-) donor.  All recipients had at least 1-month of follow-up data.

Duration

January 1, 2009 to June 30, 2011

Outcome Measures

Procurement outcomes (e.g., successful recovery, defined as procurement of a graft that is subsequently transplanted to a recipient; high-yield procurement, defined as the recovery of ≥4 organs)

Baseline Characteristics

 

AVP (n= 7,686)

No AVP (n= 4,636)

p-value

Age, years

37.52 ± 18.61 42.92 ± 17.56 <0.001

Male

4647 (60.5%) 2635 (56.8%) <0.001 

Ethnicity

White

Black

Hispanic

Other

 

4843 (63.0%)

1316 (17.1%)

1230 (16.0%)

297 (3.9%)

 

3076 (66.4%)

752 (16.2%)

629 (13.6%)

179 (3.9%)

<0.001

 

 

 

 

Donor cause of death

Cerebrovascular disease

Traumatic brain injury

Anoxia

Other

 

2754 (35.8%)

3098 (40.3%)

1620 (21.1%)

214 (2.8%)

 

1968 (42.5%)

1371 (29.6%)

1165 (25.1%)

132 (2.8%)

 

<0.001

<0.001

<0.001

0.868 

Norepinephrine infused

1513 (19.7%) 711 (15.3%) <0.001

Dopamine infused

1666 (21.7%) 1033 (22.3%) 0.432 

Epinephrine infused

251 (3.3%) 101 (2.2%) <0.001 

Phenylephrine infused

1745 (22.7%) 1234 (26.6%) <0.001 

BMI >30

1922 (25.0%) 1412 (30.5%) <0.001

Donor bacteremia

534 (6.9%) 351 (7.6%) 0.194

CDC high-risk donor

670 (8.7%)  412 (8.9%) 0.747 

Expanded criteria donors

1545 (20.1%) 1377 (29.7%) <0.001

Donor cardiac arrest

517 (6.7%) 249 (5.4%) 0.003

Results

 

AVP (n= 7,686)

No AVP (n= 4,636)

p-value

Lung recovered (one or both)

2022 (26.3%) 952 (20.5%) <0.001

Mean donor lung PO2 on 100% O2

239.885 ± 154.208 228.796 ± 149.323 <0.001 

Donor lung P/F >200

3479 (45.3%) 1948 (42.0%) <0.001 

Mean no. of organs per donor

3.75 ± 1.38 3.33 ± 1.41 <0.001 

High-yield procurement

3922 (51.0%) 1823 (39.3%) <0.001 

Adjusting the significant factors, AVP was independently associated with successful lung procurement (1.220, 95% CI 1.114-1.336; p< 0.001). The incidence of early graft failure was not changed.

Adverse Events

None disclosed

Study Author Conclusions

AVP with HRT is associated with the maintenance of lung function and a significant increase in successful organ recovery in donors without untoward effects in the recipient. AVP should be universally adopted as a component of HRT in the management of donors with neurologic death.

InpharmD Researcher Critique

The study lacks detailed information relating to donor management; thus, the study is unable to address the indications for choosing specific agents or directly compare the effects of AVP with other combinations of drugs. Additionally, pooled data from multiple transplant programs may introduce data entry variability and potential for missing data. Donors who received AVP also tended to receive more vasopressor therapy as a whole, so these results may have been slightly confounded.



References:

Callahan DS, Neville A, Bricker S, et al. The effect of arginine vasopressin on organ donor procurement and lung function. J Surg Res. 2014;186(1):452-457. doi:10.1016/j.jss.2013.09.028