eISSN: 1731-2531
ISSN: 1642-5758
Anaesthesiology Intensive Therapy
Current issue Archive Manuscripts accepted About the journal Supplements Editorial board Reviewers Abstracting and indexing Subscription Contact Instructions for authors Publication charge Ethical standards and procedures
Editorial System
Submit your Manuscript
SCImago Journal & Country Rank
1/2020
vol. 52
 
Share:
Share:
Original article

Analysis of management protocols regarding ineffective maintenance of organ functions in patients treated at the Intensive Care Unit of the University Hospital in Wroclaw

Ewa Woźnica-Niesobska
1
,
Waldemar Goździk
1
,
Jakub Śmiechowicz
1
,
Łukasz Stróżecki
1
,
Andrzej Kubler
1

1.
Department of Anesthesiology and Intensive Therapy, Wroclaw Medical University, Wroclaw, Poland
Anaesthesiol Intensive Ther 2020; 52, 1: 3–9
Online publish date: 2020/02/06
Article file
Get citation
 
PlumX metrics:
 

Intensive care units (ICUs) were founded in the middle of the 20th century as the separate therapeutic stations for patients with reversible failure of vital organs [1]. A classic example was the treatment of respiratory failure caused by the poliovirus using mechanical ventilation [2]. Over time, intensive care developed into a separate medical field; at present, thanks to the technological advances, almost all vital functions can be artificially maintained. In some ICU patients, the support of organ functions does not lead to any basic therapeutic benefits, i.e. satisfactory life after discharge from the ICU. In such cases the maintenance of organ functions only prolongs the process of dying and is of no benefits for patients. Such an approach is inconsistent with the current medical knowledge and ethics and is called a futile therapy. Many Polish and foreign research studies were focused on determining the principles of avoiding futile therapy [38]. In Poland, such principles were presented in the publication entitled “Guidelines regarding the ineffective maintenance of organ functions (futile therapy) in ICU patients incapable of giving informed statements of will” [9]. An essential element of this guidelines is the management protocol regarding futile therapy in ICU, substantiating the criteria to be used to consider the therapy futile and describing the process of withholding or withdrawing futile therapeutic interventions in a given clinical situation. To date, the information regarding implementation of guidelines into Polish ICU practice has not been published.

The present paper analyses the use of management protocols concerning futile therapy at an intensive care unit of the university hospital between 01.01.2015–31.12.2018.

METHODS

The content of management protocols on futile therapy included in guidelines were analysed. The document presents the official consensus statement, which the medical societies consulted with bioethical and legal opinions. Therefore, our analysis was not additionally approved by the local Bioethics Committee.

The protocol forms were available for the ICU personnel. The protocols were completed in the Intensive Care Unit of the University Hospital in Wroclaw, Department of Anaesthesiology and Intensive Therapy, Wroclaw Medical University and covered the period of 4 years (01.01.2015–31.12.2018).

The decision about instituting the protocol as the documentation of avoiding futile therapy was made by the ICU attending team, i.e. two specialists in anaesthesiology and intensive therapy in cooperation with the head of the Department. The decision made was discussed with the entire ICU therapeutic team and presented to the patient’s families. None of the patients taken into consideration while starting the protocols was capable of deciding about treatment unaided.

The protocol consists of 3 pages (Figure 1). The first one includes personal data of a patient, short introduction to the tenets of avoiding futile therapy and clinical aspects of the decision made. The second page contains ethical and environmental aspects of the decision, information about family members or friends that were informed about the situation, the issues discussed with them, and a list of therapeutic procedures considered futile which will be withdrawn or withheld. The third page of the protocol is the statement substantiating de-escalation of futile therapeutic procedures, signed by two specialists in anaesthesiology and intensive therapy and the physician in charge of the department. The content of protocols was statistically analysed. For higher clarity during presentation of outcomes, only the most important clinical diagnosis was selected for analysis.

FIGURE 1

Protocol of futile therapy – page 1 Protocol of futile therapy – pages 2 and 3

/f/fulltexts/AIT/39877/AIT-52-39877-g001_min.jpg

The questionnaire findings were analysed using Statistica 13.0 PL (Statsoft, Tulsa, USA). Basic descriptive statistics were calculated for quantitative variables; in the case of qualitative variables, distributions were determined with sample size and contingency tables.

RESULTS

In the years 2015–2018, 1660 patients were treated in the ICU; 557 (33.6%) died. Analysis encompassed 146 properly completed protocols (8.8%). The number of the protocols used in the individual years is presented in Table 1. The group with protocols aged 64.5 years (27–94) on average; male patients constituted 61% (89) and female patients 39% (57). Table 2 reveals the demographic data, average time between ICU admission and use of the protocol as well as average time between protocol commencement and death. The most important initial diagnosis on ICU admission in patients with protocols was presented in Table 3. The predominant diseases were heart failure or systemic infection. The main diagnoses established while implementing the protocols were listed in Table 4. The most common diagnosis was multiple organ failure, followed by permanent damage to the central nervous system (CNS).

TABLE 1

Percentages of protocols in relations to the number of patients in the individual years

YearNumber of patientsNumber of protocols%
2015348298.3
2016420235.5
2017408368.8
20184225813.7
In total16601468.8
TABLE 2

Information on patients with protocols regarding futile therapy

Age 64.5 years on average (27–94)
GenderMen – 89 (61%)
Women – 57 (39%)
Mean time between ICU admission and protocol institution15.9 ± 14.4 days
Mean time between protocol institution and death7.8 ± 10.5 days
TABLE 3

Patients with protocols regarding futile therapy – preliminary diagnosis

Cardiovascular system failure (including the condition after cardiac arrest) 28%
Sepsis/Septic shock25%
Post-surgery complications (undefined)10%
Central nervous system diseases9%
Central nervous system injuries8%
Respiratory disorders8%
Neoplastic diseases7%
Hepatic failure3%
Multiple organ failure2%
TABLE 4

Patients with protocols regarding futile therapy – diagnosis on protocol implementation

Multiple organ failure 56%
Permanent central nervous system injury39%
Respiratory failure3%
Circulatory collapse2%

Generally, the decisions to implement the protocol were taken by the team of ICU physicians; in 36 cases (24.7%) they consulted with other specialists, mainly neurosurgeons, neurologists, vascular surgeons and general surgeons. Family members were consulted repeatedly. Those informed most frequently were daughters (45%), wives (32%), sons (24%) and husbands (8%). “Family conferences”, i.e. meetings with many family members with many members of therapeutic team, were carried out. Personal conflicts or legal conflicts were avoided; none of the cases with protocols was brought into the court.

The most common procedure to avoid futile therapy was to withhold certain forms of therapy. The general number of withheld forms of therapy was 13-fold higher than the number of withdrawn procedures (Table 5). The procedures withheld most frequently included cardiopulmonary resuscitation and mechanical maintenance of organ functions, which were withheld in 90% of protocols (Table 6).

TABLE 5

Number of withheld and withdrawn procedures

Total number of protocols 146
Total number of withheld protocols1164
Number of withheld procedures per 1 protocol7.8
Total number of withdrawn procedures89
Number of withdrawn procedures per 1 protocol0.6
TABLE 6

Procedures of withholding/withdrawing the therapy

ProcedureWithholding/withdrawing therapy
% of withholding in relations to the total number of protocols (n)% of withdrawals in relations to the total number of protocols (n)
Cardiopulmonary resuscitation97.3 (142)4.8 (7)
Mechanical circulatory support97.3 (142)1.4 (2)
Cardiac electrotherapy95.9 (140)2.1 (3)
Extracorporeal respiratory support94.5 (138)2.7 (4)
Extracorporeal liver support94.5 (138)2.1 (3)
Surgical procedures and other invasive interventions76.7 (112)1.4 (2)
Renal replacement therapy65.8 (96)19.2 (28)
Pharmacological circulatory support58.2 (85)14.4 (21)
Transfusion of blood preparations56.8 (83)1.4 (2)
Parenteral nutrition52.1 (76)4.8 (7)
Mechanical ventilation5.5 (8)0.7 (1)
Antibiotic therapy2.7 (4)0

The decisions to withdraw the therapy were much rarer (Table 6). The procedures most frequently withdrawn included renal replacement therapy and pharmacological support of the cardiovascular system (infusions of catecholamines).

Not all the patients with protocols died in the ICU. In total, 119 died, which constituted 81.5% of deaths of patients with protocols. The remaining patients, n = 27, died during further hospital treatment outside the ICU (Table 7). Moreover, the percentage of all deaths of patients with protocols versus the number of ICU deaths was 26.2%.

TABLE 7

Number of deaths of patients with protocols

Year (number of protocols)Number of ICU deaths (deaths in ICU in total)% of ICU deaths of patients with protocols% of deaths of patients with protocols to the total number of deaths in the ICU
2015 (29)27 (117)93.123.1
2016 (23)18 (150)78.312.0
2017(36)30 (141)83.321.3
2018 (58)44 (149)75.829.5
Total number of deaths119 (557)81.521.4

DISCUSSION

The circumstances leading to futile therapy often occur during ICU treatment. The avoidance of such interventions by physicians is prevalent. According to the questionnaire study published in 1999, involving 16 western European countries, 93% of ICU physicians withheld certain therapeutic interventions and 77% of them withdrawn some procedures during their medical practice due to their futility [10]. The findings of a similar study carried out 12 years later among Polish anaesthesiologists were almost identical (93% and 75%, respectively) [11]. Noteworthy, only 10% of Polish respondents recorded their interventions in hospital records, as compared to 58% in Europe.

The lack of written records of management regarding withholding or withdrawing futile therapy is an obvious medical malpractice. It gives the impression that therapeutic decisions are concealed as if they were improper. On the other hand, futile therapy is generally considered a medical, ethical and legal malpractice [12]. In Poland, medical and ethical arguments explicitly expressed in the guidelines substantiate the decisions of de-escalation of futile therapy; nevertheless, the legal stance has not been clearly formulated and requires corrections [13]. Therefore, the protocol of management attached to the guidelines was designed to clearly substantiate the medical decisions regarding futile therapy and protect against potential negative consequences of legal action. Similar protocols were constructed in numerous countries to properly document the activities aimed at de-escalation of futile therapy [14, 15].

According to the analysis of withholding or withdrawing futile therapy based on the ICON study, evaluating ICUs worldwide published recently [16], the average frequency of withholding or withdrawing futile therapy was 13% and was similar to that observed in Wroclaw (9%). In the Wroclaw study, hospital mortality of patients with protocols was 100% while ICU mortality was 81.5%; in the worldwide study, the hospital mortality was 69%. The differences in percentages were associated with inter-country variations in the principles for making the decisions of futile therapy de-escalation. Recently, global steps have been taken to standardise the end-of-life management of patients dying in ICUs. The preliminary findings presented in the WELPICUS study have evidenced that world-wide consensus as to the key definitions and statements regarding end-of-life care in ICU patients can be be achieved [17].

In the protocols analysed, the decision to withhold therapy were significantly more frequent, as compared to the decisions of withdrawing the procedures. And this is a prevalent phenomenon. Although both types of management do not differ ethically, in clinical practice, the withdrawal of the therapy already administered is more difficult than withholding of therapy, which is likely to be asso-ciated with the lack of detailed protocols of mana-gement in such cases [18].

In our opinion, proper communication with the family and relatives of the patient dying in the ICU is pivotal. In the cases discussed, special attention was paid to comprehensive and multifaceted discussions between the staff and family members. The mean time between the protocol initiation and death was 8 days, which seems to be enough to establish in-depth contact with the patient’s family. Much has to be done to optimise the proper strategy of communication with the family and friends of terminally ill patients dying in ICUs [19].

The study limitations are as follows: 1) the study involves a single centre; therefore, it does not provide complete country-wide information on the use of protocols of management regarding futile therapy in ICUs, 2) the protocol described in the guidelines is only a suggestion; it has not been validated or verified and presumably requires some amendments and modifications.

Nevertheless, the study is the first broader analysis concerning the implementation of the guidelines to ICU practice in Poland and should be an incentive to carry out multi-centre research studies. The clinical observations should lead to the protocol optimisation of management and to updating the guidelines. A desirable objective is to formally regard the amended version of guidelines with the protocol as part of standard medical record documentation required at intensive care units.

CONCLUSIONS

In the years 2015–2018, the protocols of mana-gement regarding futile therapy were used in 9% of patients treated in the Intensive Care Unit of the Teaching Hospital in Wroclaw. All patients with protocols died during the hospital treatment. Withholding of resuscitation and mechanical maintenance of organ functions was found to be significantly more frequent than withdrawing of the procedures already undertaken. Multi-centre analysis of the use of protocols of management regarding futile therapy is recommended to optimise the care of patients dying in the ICU.

ACKNOWLEDGEMENTS

Financial support and sponsorship

none.

Conflicts of interest

none.

References

1 

Marshall JC, Bosco L, Adhikari NK, et al. What is an intensive care unit? A report of the task force of the World Federation of Societies of Intensive and Critical Care Medicine. J Crit Care 2017; 37: 270-276. doi: 10.1016/j.jcrc.2016.07.015.

2 

Reisner-Senelar L. The birth of intensive care medicine: Bjorn Ibsen’s records. Intensive Care Med 2011; 37: 1084-1086. doi: 10.1007/s00134-011-2235-z.

3 

SIAARTI–Italian Society of Anaesthesia Analgesia Resuscitation and Intensive Care Bioethical Board. End-of-life care and the intensivist: SIAARTI recommendations on the management of the dying patient. Minerva Anesthesiol 2006; 72: 927-963.

4 

Valentin A, Druml W, Steltzer H, Wiedermann CJ. Recommendations on therapy limitation and therapy discontinuation in intensive care units: consensus paper of the Austrian associations of intensive care medicine. Intensive Care Med 2008; 34: 771-776. doi: 10.1007/s00134-007-0975-6.

5 

Myatra SN, Salins N, Iyer S, et al. End-of-life care policy: an integrated care plan for the dying: a joint position statement of the Indian Society of Critical Care Medicine (ISCCM) and the Indian Association of Palliative Care (IAPC). Indian J Crit Care Med 2014; 18: 615-635. doi: 10.4103/0972-5229.140155.

6 

Truog RD, Campbell ML, Curtis JR, et al. Recommendations for end-of-life care in the intensive care unit: a consensus statement by the American College of Critical Care Medicine. Crit Care Med 2008; 36: 953-963. doi: 10.1097/CCM.0B013E3181659096.

7 

Bosslet GT, Pope TM, Rubenfeld GD, et al.; American Thoracic Society ad hoc Committee on Futile and Potentially Inappropriate Treatment; American Thoracic Society; American Association for Critical Care Nurses; American College of Chest Physicians; European Society for Intensive Care Medicine; Society of Critical Care. An official ATS/AACN/ACCP/ESICM/SCCM policy statement: responding to requests for potentially inappropriate treatments in intensive care units. Am J Respir Crit Care Med 2015; 191: 1318-1330. doi: 10.1164/rccm.201505-0924ST.

8 

Myburgh J, Abillama F, Ciumello D, et al.; Council of the World Fede-ration of Societies of Intensive and Critical Care Medicine. End-of-life care in the intensive care unit: Report from the Task Force of World Federation of Societies of Intensive and Critical Care Medicine. J Crit Care 2016; 34: 125-130. doi: 10.1016/j.jcrc.2016.04.017.

9 

Kübler A, Siewiera J, Durek G, Kusza K, Piechota M, Szkulmowski Z. Guidelines regarding the ineffective maintenance of organ functions (futile therapy) in ICU patients incapable of giving informed statements of will. Anaesthesiol Intensive Ther 2014; 46: 215-220. doi: 10.5603/AIT.a2014.0038.

10 

Vincent JL. Forgoing life support in western European intensive care units: the results of an ethical questionnaire. Crit Care Med 1999; 27: 1626-1633.

11 

Kübler A, Adamik B, Lipinska-Gediga M, Kedziora J, Strozecki L. End-of-life attitudes of intensive care physicians in Poland: results of a national survey. Intensive Care Med 2011; 37: 1290-1296. doi: 10.1007/s00134-011-2269-2.

12 

Rubenfeld GD. Principles and practice of withdrawing life sustaining treatments. Crit Care Clin 2004; 20: 435-451. doi: 10.1016/j.ccc.2004.03.005.

13 

Szeroczyńska M. Withdrawing and withholding futile therapy–de lege lata and de lege ferenda. Medycyna Paliatywna 2013; 5: 31-40.

14 

Sjökvist P, Sundin PO, Berggren L. Limiting life support. Experience with the special protocol. Acta Anaesthesiol Scand 1988; 42: 232-237.

15 

Holzapel L, Demingeon G, Piralla B, Biot L, Nallet B. A four-step protocol for limitation of treatment in terminal care. An observational study in 475 intensive care unit patients. Intensive Care Med 2002; 28: 1309-1315. doi: 10.1007/s00134-002-1370-y.

16 

Lobo SM, De Simoni FH, Jakob SM, et al.; ICON investigators. Decision-making on withholding or withdrawing life support in the ICU: a worldwide perspective. Chest 2017; 152: 321-329. doi: 10.1016/j.chest.2017.04.176.

17 

Sprung CL, Truog RD, Curtis JR, et al. Seeking worldwide professional consensus on the principles of end-of-life care for the critically ill. The Consensus for Worldwide End-of-Life Practice for Patients in Intensive Care Units (WELPICUS) study. Am J Respir Crit Care Med 2014; 190: 855-866. doi: 10.1164/rccm.201403-0593CC.

18 

Sprung CL, Paruk F, Kissoon N, et al. The Durban World Congress Ethics Round Table Conference Report: I. Differences between withholding and withdrawing life-sustaining treatments. J Crit Care 2014; 29: 890-895. doi: 10.1016/j.jcrc.2014.06.022.

19 

Cook D, Rocker G. Dying with dignity in the intensive care unit. N Engl J Med 2014; 370: 2506-2514. doi: 10.1056/NEJMra1208795.

This is an Open Access journal, all articles are distributed under the terms of the Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International (CC BY-NC-SA 4.0). License (http://creativecommons.org/licenses/by-nc-sa/4.0/), allowing third parties to copy and redistribute the material in any medium or format and to remix, transform, and build upon the material, provided the original work is properly cited and states its license.
 
Quick links
© 2024 Termedia Sp. z o.o.
Developed by Bentus.